Medical device and method

ABSTRACT

A vessel-occluding medical device for the use in diagnosis and/or treatment of cardiovascular disease in the human body includes an outer tube, an inner tube slidably housed within the outer tube, and a tubular sleeve comprising a generally U-shaped, direction reversing region, which moves along the length of the tubular sleeve, to assume radially contracted and radially expanded state as the inner and outer tubes move between the first and second positions. When the tubular sleeve is in the radially expanded state, the inner portion of the tubular sleeve has a funnel-shaped surface and a longitudinally-extending opening to permit material to pass therethrough for receipt of material into the inner tube.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation application of U.S. patentapplication Ser. No. 13/725,871, filed Dec. 21, 2012, which is acontinuation application of U.S. patent application Ser. No. 12/477,371filed Jun. 3, 2009, which is a continuation-in-part of U.S. patentapplication Ser. No. 10/824,779 filed Apr. 15, 2004. The disclosures ofall the above-referenced patent applications are hereby fullyincorporated by reference.

BACKGROUND

Occlusive vascular disease is a common ailment in people resulting inenormous costs to the health care system. Blood clots and theiraccompanying plaque buildup are the most common type of occlusion.Removal of this disease from the body has been studied for several yearsand many techniques (devices and methods) have been studied andpracticed. Sometimes the diseased/stenosed areas of the vessels may beremoved by use of Embolectomy, Atherectomy, thrombolysis, etc. orangioplasty and/or stenting can repair the diseased vessel but all ofthese are not always effective. The deposit of sinuous plaque(arteriosclerosis) to the inner wall of arteries usually precedes clotformation. Several expensive devices (dilatation balloons, stents,mechanical cutters, etc.) have been introduced to fight this vascularocclusive disease, but none of which has proven to be the ‘magic bullet’to treat this ubiquitous disease. Even when effective, thesetechnologies often are effective for a short period of time. Because ofthe various problems with all of the techniques and approaches tosolving this medical condition, there exists no particular method ordevice that is considered the most accepted mode of treatment.

Unfortunately, cancer too is a common ailment resulting in over 1,500deaths every day in the U.S. (550,000 every year; the number two killerin the U.S. after vascular disease). Therapy modalities for cancer areplentiful and continued to be researched with vigor. Still, thepreferred treatment continues to be physical removal of the cancer. Whenapplicable, surgical removal is preferred (breast, colon, brain, lung,kidney, etc.). Often these cancers occur in the body channels that areactually not dissimilar to occlusions in the vasculature.

Even though there are many techniques and devices known in the art forremoving blockages in the tubular channels of the body and/or forbypassing them with autogenous or synthetic means (both surgically andvia a percutaneous, less invasive technique) and other passageways ofthe human body as well as removing other diseased tissue, there is aneed to removed the diseased tissue and re-join healthy pieces of thetissue once the diseased tissue has been removed. This removed tissuemay be removed because of many reasons some of which are (but certainlynot limited to) cancerous or potentially cancerous material, vasculardisease (or potential vascular disease), trauma to tissue, congenitaldisease of the tissue, etc.

BRIEF SUMMARY OF THE INVENTION

A first aspect of the invention is directed to a catheter/dilatorassembly comprising a catheter assembly, a dilator and a compressionelement. The catheter assembly comprises a catheter, having a proximalcatheter end, a distal catheter end, a lumen, and an outer cathetersurface, and a material-directing element, movable between radiallyexpanded and radially collapsed states, secured to and extending pastthe distal catheter end, the material-directing element having an axiallength when in the radially collapsed state. The dilator comprises ahollow shaft within the lumen of the catheter, the hollow shaft havingan outer shaft surface, a proximal shaft end, a distal shaft end and arecessed region in the outer shaft surface at the distal shaft end. Therecessed region and the material-directing element are generally alignedwith one another. A compression element covers the material-directingelement to temporarily retain the material-directing element in aradially collapsed state. The recessed region is sized for receipt of atleast substantially the entire axial length of the material-directingelement so to reduce the radial cross-sectional dimension of theassembly at the material-directing element.

A second aspect of the invention is directed to a method for assemblinga catheter/dilator assembly. A catheter assembly is selected. Thecatheter assembly comprises a catheter, having a proximal catheter end,a distal catheter end, a lumen, and an outer catheter surface, and amaterial-directing element, movable between radially expanded andradially collapsed states, secured to and extending past the distalcatheter end. The material-directing element has an axial length when inthe radially collapsed state. A hollow shaft of a dilator is insertedthrough the proximal catheter end and into the lumen of the catheter. Arecess formed in the distal shaft end of the hollow shaft is positionedto underlie the material-directing element. The material-directingelement is placed in the radially collapsed state. A first sleeve isslid in a proximal direction to a first position covering the distalshaft end of the dilator and over the material-directing element tomaintain the material-directing element in the radially collapsed state.

A third aspect of the invention is directed to a dilator assembly. Anelongate dilator comprises proximal and distal portions, a dilator tipat the distal portion, and a dilator lumen extending from the dilatortip to at least a first position along the dilator. The dilator alsocomprises a guide wire pathway extending from a second position at theproximal portion of the dilator to the first position. The dilator hasan opening at the first position connecting the guide wire pathway andthe dilator lumen. A flexible guide wire extends along the guide wirepathway, through the opening, through the dilator lumen and out of thedilator tip.

A fourth aspect of the invention is directed to a rapid exchange dilatorassembly. A catheter comprises a catheter lumen extending between adistal catheter end and a proximal catheter end. An elongate dilator,removably housed within the catheter lumen, comprises a proximal portionextending to a proximal dilator end, a distal portion extending to adilator tip, and a dilator lumen extending from the dilator tip to atleast a first position along the dilator. The dilator comprises a guidewire pathway extending from the proximal portion of the dilator to thefirst position. The dilator has an opening at the first positionconnecting the guide wire pathway and the dilator lumen. A flexibleguide wire, comprising a guide wire proximal end and a guide wire distalend, extends along the guide wire pathway, through the opening, throughthe dilator lumen and out of the dilator tip. The guide wire proximalend and the proximal dilator end are positioned proximally of theproximal catheter end, the guide wire distal end and the distal dilatorend are positioned distally of the distal catheter end. Therefore, whenthe assembly is at a desired position within a body, the dilator can beremoved leaving the catheter and guide wire in position.

A fifth aspect of the invention is directed to a method for providingaccess to a target site within a tubular structure of a patient. Adistal catheter end of a first, guide catheter is positioned at a firstposition within a tubular structure of a patient. A rapid exchangedilator assembly is passed into the first catheter, the rapid exchangedilator assembly comprising a second catheter, the second cathetercomprising a removable dilator, a guide wire and a second catheterlumen, the second catheter lumen housing the dilator and the guide wire.The dilator is removed from the patient leaving the second catheter andthe guide wire within the patient. An operational device is passedthrough the second catheter for performing a procedure at the targetsite.

A sixth aspect of the invention is directed to funnel cathetercomprising an outer tube, an inner tube slidably located within theouter tube, and a tubular sleeve having first and second ends andmovable between a radially expanded, use state and a radiallycontracted, deployment state. The first end of the sleeve is secured toa distal end of the outer tube. The second end of the sleeve is securedto a distal end of the inner tube. The sleeve has a movable, generallyU-shaped direction-reversing region so that when the first and secondends move relative to one another the position of thedirection-reversing region moves relative to the distal ends of theinner and outer tubes, the direction-reversing region constituting thedistal funnel catheter end.

A seventh aspect of the invention is directed to a method for deployinga material-directing element within a tubular structure within apatient. A funnel catheter, having a distal funnel catheter end, isselected. The funnel catheter comprises an outer tube, an inner tubeslidably located within the outer tube, a tubular sleeve having firstand second ends and movable between a radially expanded, use state and aradially contracted, deployment state, the first end of the sleeve beingsecured to a distal end of the outer tube, the second end of the sleevebeing secured to a distal end of the inner tube. The sleeve has amovable, generally U-shaped direction-reversing region, thedirection-reversing region constituting the distal funnel catheter end.The funnel catheter is deployed with the sleeve in a reduced diameter,deployment state and with the sleeve being generally parallel to theouter and inner tubes. The direction-reversing region is positioned at achosen position within a tubular structure within a patient. The distalends of the inner and outer tubes are moved relative to one anothercausing: the position of the direction-reversing region to move relativeto the first and second ends, the sleeve to form a distally-openingmaterial-directing funnel, the funnel having a distal funnel portion anda proximal funnel portion, and the distal funnel portion to contact theinner wall of the tubular structure.

An eight aspect of invention is directed to method for making a funnelcatheter. Material is wound onto a mandril to create a tubular braidedsleeve having a proximal portion, a distal portion, a proximal end, anda distal end. The tubular braided sleeve is removed from the mandril.The proximal end is secured to a first position on an outer tube and thedistal end is secured to a second position on an inner tube to create afunnel catheter.

A ninth aspect of the invention is directed to a balloon funnel cathetercomprising a shaft, having an end, a main lumen and an inflation lumen,and an annular balloon mounted to the end of the shaft and fluidlycoupled to the inflation lumen for movement between a radiallycontracted, uninflated state and a radially expanded, inflated state.The balloon defines an open region opening into the main lumen when inthe inflated state. The balloon extends distally past the end of theshaft when in the inflated state.

A tenth aspect of the invention is directed to a method for securing atubular braid to a tube. A first end of a tubular braid is brought intoengagement with an end portion of a tube, said end portion comprising atemporarily softenable tube material. The temporarily softenable tubematerial is then softened. The end portion of the tube and the first endof the tubular braid are merged into one another to create a tubematerial/tubular braid matrix.

An eleventh aspect of the invention is directed to a method forcontrolling the shape of a radially expandable and contractible tubularbraid device. A radially expanded shape is chosen for the braid devicewhen the braid device is in a radially expanded state, the radiallyexpanded shape having a length and different cross-sectional dimensionsat selected positions along the length. A material is selectivelyapplied to at least some of the selected positions along the braiddevice. The stretch resistance of the material is adjusted according tothe selected positions. Therefore, the different stretch resistances atthe selected positions cause the braid device to assume the chosenradially expanded shape when the braid device is in the radiallyexpanded state.

A twelfth aspect of the invention is directed to a method for impartinga shape to a thermoplastic membrane. At least a portion of a radiallyexpandable device is surrounded with a thermoplastic membrane. Theradially expandable device is radially expanded to a chosen expandedconfiguration thereby reshaping the thermoplastic membrane to assume anexpanded state corresponding to the chosen expanded configuration. A setis imparted to the thermoplastic membrane while in the expanded state.

A thirteenth aspect of the invention is directed to an anastomoticmedical device comprising a tube, having first and second ends and alumen extending therebetween, and an anchor member at the first end forsecuring the first end to a first tubular structure of a patient, thefirst tubular structure having a first open interior, with the firstopen interior opening into the lumen.

A fourteenth aspect of the invention is directed to an anastomoticmedical assembly comprising first and second anastomotic medicaldevices. The first anastomotic medical device comprises a first tube,having first and second ends and a first lumen extending therebetween,and a first anchor member at the first end of the first tube forsecuring the first end of the first tube to a first tubular structure ofa patient. The first tubular structure has a first open interior, withthe first open interior opening into the first lumen. The secondanastomotic medical device comprises a second tube, having first andsecond ends and a first lumen extending therebetween, and a secondanchor member at the first end of the second tube for securing the firstend of the second tube to a second tubular structure of a patient. Thesecond tubular structure has a second open interior, with the secondopen interior opening into the second lumen. The second ends of thefirst and second tubes are connected to one another to create a fluidpath between the first and second anchor members. Therefore, the firstand second open interiors of the first and second tubular structures ofthe patient may be fluidly connected.

Various features and advantages of the invention will appear from thefollowing description in which the preferred embodiments have been setforth in detail in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS

Certain preferred embodiments and modifications thereof will becomeapparent to those skilled in the art from the detailed description belowhaving reference to the figures that follow.

FIGS. 1 and 2 illustrate an expandable element guide wire in radiallycontracted and radially expanded states;

FIG. 3 illustrates an alternative embodiment of the expandable elementguide wire of FIG. 2;

FIG. 4 illustrates a needle inserted into a graft near an occlusion;

FIGS. 5-7 illustrate insertion of an expandable element guide wirethrough the needle of FIG. 4, expanding the expandable element and thenremoving the needle leaving the guide wire in place;

FIG. 8 illustrates a recessed dilator;

FIG. 9 illustrates a funnel catheter assembly;

FIG. 9A is a cross sectional view taken long line 9A-9A of FIG. 9;

FIG. 10 is an isometric view of the split stopper sleeve of FIG. 9;

FIG. 11 shows inserting the recessed dilator of FIG. 8 into the funnelcatheter assembly of FIG. 9 to create a funnel catheter/dilatorsubassembly;

FIGS. 12 and 13 show movement of the compression sleeve over the funnelelement of FIG. 11;

FIG. 14 is an enlarged side view of a tearaway sleeve;

FIG. 14A is a cross sectional view taken long line 14A-14A of FIG. 14;

FIG. 15 illustrates sliding the tearaway sleeve of FIG. 14 onto thesubassembly of FIG. 11 to create a catheter/dilator assembly;

FIG. 16 illustrates the result of sliding the assembly of FIG. 15 overthe expandable element guide wire of FIG. 7;

FIG. 17 illustrates the assembly of FIG. 16 after the tearaway sleevehas been pulled proximally to allow the funnel to expand;

FIG. 18 shows manipulating the apparatus of FIG. 17 to drive theocclusion into the funnel;

FIG. 18A is an enlarged cross sectional view taken long line 18A-18A ofFIG. 18;

FIG. 19 is an enlarged side view of the proximal and distal portions ofa rapid exchange dilator assembly;

FIG. 20 is a partial cross sectional view of the distal end of theassembly of FIG. 19;

FIGS. 21 and 22 are cross sectional views taken along lines 21-21 and22-22 of FIGS. 19 and 20, respectively;

FIG. 23 shows a heart having a bypass graft connecting the ascendingaorta and a coronary artery;

FIGS. 24-28 illustrates the use of the rapid exchange dilator assemblyof FIG. 19 to access a position along the bypass graft of FIG. 23;

FIGS. 29 and 30 are cross sectional views of the distal ends of twoembodiments of a funnel catheter;

FIG. 31 shows the funnel catheter of FIG. 30 in a radially expandedstate;

FIG. 32 shows an alternative embodiment of the funnel catheter of FIG.31 with an elastic film on the outer surface;

FIGS. 33 and 34 show the placement and use of the funnel catheter ofFIG. 30 within a vessel;

FIG. 35 illustrates a mandril having tapered proximal and distalportions wound in a braided fashion to create a braided structure;

FIGS. 36-39 show the braided structure of FIG. 35 used to make a funnelcatheter, the braided structure being in an expanded diameter state inlarger diameter and smaller diameter vessels;

FIG. 40 shows an alternative to the embodiment of FIG. 37;

FIGS. 41 and 42 show two different embodiments to the embodiment of FIG.36;

FIGS. 43 and 44 show two additional embodiments of the braided structureof FIG. 35;

FIGS. 45 and 46 show an alternative winding pattern to create windingsmore closely spaced at the proximal portion than at the distal portion;

FIGS. 47 and 48 are similar to FIGS. 36 and 37 but use the windingpattern of FIG. 45;

FIG. 49 shows an alternative winding pattern to create windings moreclosely spaced at the distal portion than at the proximal portion;

FIGS. 50 and 51 are similar to FIGS. 47 and 48 but use the windingpattern of FIG. 49;

FIGS. 52 and 53 show a balloon funnel catheter within a vessel near anobstruction in radially expanded and radially contracted states;

FIG. 54 is an enlarged partial cross sectional view of the balloon ofFIG. 53;

FIGS. 55-58 illustrate securing an end of a tubular braid within the endportion of a tube using a heated tool and a mandril;

FIGS. 59 and 60 illustrate two embodiments of a radially expandable andcontractible braided device in which the expansion is controlled by theapplication of a material over portions of their lengths;

FIGS. 61 and 62 illustrate the use of a radially expandable device toimpart a shape to a membrane;

FIG. 63 shows a first end of anastomotic medical device placed within atubular structure;

FIGS. 64 and 65 show the second end of the tube of the device of FIG. 63with an actuator pulled proximally in FIG. 65 so to expand the tubularbraided anchor member of FIG. 63;

FIG. 66 shows the device of FIG. 63 with the tubular braid anchor memberin a radially expanded state and the dilator and guide wire removed;

FIG. 67 is similar to FIG. 66 but shows the use of hooks to help securethe tubular braid anchor member to the tubular structure;

FIGS. 68 and 69 show a tubular mesh braid in axially compressed andaxially expanded states;

FIG. 70 is similar to FIG. 68 but shows the use of hooks to help securethe tubular mesh braid to a vessel wall;

FIG. 71 illustrates a tubular braided type of anastomotic medical devicecovering the opposed ends of a severed tubular structure;

FIG. 72 illustrates an internally applied tubular braided type ofanastomotic medical device used to secure the ends of a severed tubularstructure;

FIGS. 73 and 74 are similar to FIGS. 71 and 72 but include the use ofhooks to help secure the anastomotic medical devices to the tubularstructures;

FIGS. 75 and 76 show two different types of variable porosityanastomotic medical devices;

FIG. 77-80 illustrate malecot-type of anastomotic medical devices inradially expanded and radially contracted states;

FIGS. 81 and 82 show a variable porosity expandable device in radiallycontracted and radially expanded states;

FIGS. 83 and 84 show a spiral ribbon type of radially expandable andcontractible device in radially contracted and radially expanded states;

FIG. 85 is an end view of a coiled cylinder type of radially expandableand radially contractible device;

FIGS. 86-91 show different embodiments of a malecot-type of anastomoticmedical device in radially expanded and radially contracted states;

FIGS. 92 and 93 show a self expanding braided type of anastomoticmedical device in a radially contracted state within an outer tube inFIG. 92 and in a radially expanded state after being extended from theouter tube in FIG. 93;

FIG. 94 illustrates an alternative to the tubular braid anchor member ofFIG. 63 in which one or two radially expandable mechanisms are used toengage the periphery of the opening in the tubular structure; and

FIGS. 95-97 illustrate a tubular mesh braid at the distal end of an endodevice at different states within a tubular structure.

DETAILED DESCRIPTION OF THE INVENTION

There is a continuing need for improved medical devices and methods tomeet some or all the following objectives.

The first objective is to reduce cost. This is particularly important inrecent years where it is clear for safety and sanitary reasons thatthese will be single use devices. A device, even though it performs afunction in some improved manner, will not be widely used if it isconsiderably more costly than the alternatives available.

A second objective is to provide a device that is simple to use and in avery real sense simple to understand. This will encourage its adoptionand use by medical personnel. It will also tend to keep cost low.

The third objective is to provide a device that entails a procedure withwhich the medical profession is familiar so that the skills that havebeen learned from previous experience will continue to haveapplicability.

A fourth objective relates to the effectiveness and thoroughness withwhich the device performs, such as blockage removal or anastomoticdevice placement. For example, it is important that a maximum amount ofthe blockage be removed; recognizing that no device is likely to provideone hundred percent removal. With regard to bypassing or re-joining, itis important that an optimum amount of the tissue be removed andtherefore replaced; recognizing that no device is likely to provide onehundred percent optimization.

A fifth objective concerns safety; a matter, which is often so criticalas to trump the other considerations. It is important to avoid tissuetrauma. In many circumstances, it is critically important to, forexample, avoid breaking up a blockage in a fashion that leads toflushing elements of the blockage throughout the body involved. In thecase of using an anastomatic device in the tubular channels of the body,it is critically that the joining of the anastomosis does so whileminimizing tissue trauma. Often this trauma is not realized immediatelyafter surgery. Even further, leakage must be kept near zero.

There are trade-offs in design considerations to achieve the above fiveinterrelated objectives. Extreme simplicity and a very simple proceduremight over compromise safety. Addressing all of these considerationscalls for some trade-off between the objectives.

Clot Dragger Lock

One aspect of the instant invention relates to a locking mechanism forthe blocking or engaging element. Of particular relevance is the lockingmechanism of the engaging element. One such preferred embodimentincorporates an interference fit when and inner and outer slidableelongate member is used. Once deployed, the force required to keep theengaging element is usually small in relation to the force required todeploy (in the case of a non-self-expanding mechanism). In this case, aslight interference fit between the inner and outer slidable elongatemembers can be overcome easily by the interventionalist, but when theengaging or blocking element is deployed (partially or fully), theinterference fit creates enough force of the system to remaineddeployed. The same invention could be used in the case where either theengaging element or blocking element is self-expanding, but in this casethe interference fit would keep either element in the un-deployed,un-expanded condition.

This aspect is particularly useful for the engaging element because suchan interference fit can be constructed particularly small. In the caseof where the matter removal system of the instant invention is usedpercutaneously (through the skin) and a needle is used for the initialentry of the engaging element, it may be inserted through the smallneedle (usually 19, 18 or 21 gauge needle that is typically used forsuch intervention) and then deployed. In this case the needle is removedand it needs to be removed over the elongate shaft of the engagingelement (wire guide). In order for it to be removed easily, the lockingmechanism must be small or negligible with respect to the shaft of theelongate engaging element. A preferred embodiment of this lockingmechanism in the case where the engaging element has an inner elongatemember is to put a slight bend or kink in the inner member thatinterferes/impinges against an outer tubular elongate member. Inparticular, there may be three components to the outer tubular elongatemember to facilitate said locking of the engaging element. The firstcomponent is the main and longest part of the shaft of the elongatemember. This material can be matched to the required characteristicsrequired for the shaft such as torqueability, steeriblity, flexuralmodulus, softness, stiffness, etc. This first component may be attachedto the proximal side of the engaging element mechanism, but not attachedto the inner tubular or wire elongate member contained within. Thesecond component could be located proximal to the main shaft. Thisembodiment would be a handle type tubular element that would be sized tofit the physician's fingers, approximately 0.5-2.0 inches in length. Itwould not be glued or otherwise attached to the inner member. It wouldbe manufactured of a material that might be different from the mainshaft where characteristics of the first and second component could bedifferent. The outside surface of this handle may be roughened or havesome high friction coating put on it that would aid with the physiciangrasping the handle. This second component may require some ‘stiffness’in it in such a case where the inner tubular or wire elongate member iskinked or otherwise bent. This second material may be harder or stifferso that the kink on the inner member that prevents axial motion does notflex or distort the material. This second material stiffness might besuch that it is important that the kink or bend in the inner memberinterfere enough and have enough force to hold the expanding element inplace once deployed (or un-deployed in the case of the expandingmechanism being in the smaller unexpanded condition). Further, to createthe appropriate interference, the inner diameter of this secondcomponent could be even smaller than the inner tubular or wire elongatemember. It is possible to design an inner diameter of this secondcomponent to be 0.0001 to 0.002 inches smaller in diameter than theinner elongate member. This interference fit would be sufficient to holdthe expanding mechanism expanded or unexpanded yet the interferenceforce would not be too great that the physician could not overcome theforce easily to deploy or un-deploy the mechanisms. Further acombination of smaller or equal or slightly larger inner diameter ofthis second component than the diameter of the inner elongate membercould be coupled with the kink/bend/ferrule or other diametricaladdition such as a drop of glue or epoxy to cause a brief interferencefit could be used for locking either expandable mechanism.

The third component may be approximately the same outside diameter ofthe first and second component, but would like be glued or otherwiseattached to the inner tubular member by glue or other adhesive, heatstaking (or melting the polymeric handle to the inner member) or a‘pressed’ interference fit so that this third component would move intandem with the inner elongate member.

Hence in such a configuration, the physician would use his/her two hands(two fingers on each hand) to deploy and un-deploy and lock and unlockthe expanding and contracting mechanisms respectively. This isaccomplished by the physician grasping the third component with one handand the second component with the second hand and pulling the twocomponents apart so that a space would be created between the twocomponents nearly equal to the distance that is changed from thedeploying/undeploying distal element.

To aid with ease of use, the two handles may be color coded so that thephysician would realize the difference between the two handles and foreducation in training them to use the locking mechanism.

FIGS. 1 and 2 illustrate an expandable element guide wire 10 comprisingouter and inner guide wires 12, 14. A braided expandable element 16 hasa proximal end 18 secured to the distal end 20 of outer guide wire 12and a distal end 22 secured to the distal end 24 of inner guide wire 14.The proximal end 24 of inner guide wire 14 has a deployment grip 26secured thereto. The proximal end 28 of outer guide wire 12 is spacedapart from deployment grip 26 to create a locking region 30. Relativemovement between the outer and inner guide wires 12, 14 can berestricted by a guide wire lock 31. Guide wire lock 31 includes a kink32 in inner guide wire 14 along region 30 and a kink engagement sleeve34 slidably mounted on region 30 of inner guide wire 14. Kink engagementsleeve 34 may be secured to outer guide wire 12 or not. A suggested inFIG. 2, pulling on inner guide wire deployment grip 26 to separateproximal ends 24, 28, while maintaining kink engagement sleeve 34adjacent to proximal end 28 of outer guide wire 12, causes kink 32 tomove within the deformable kink engagement sleeve 34. The resistance tokink 32 moving within kink engagement sleeve 34 maintains expandableelement 16 at the radially contracted condition of FIG. 1 or at any of arange of radially expanded conditions, such as that shown in FIG. 2.Expandable element 16 may be another type of expandable element, such asa malecot type of expandable element (that is a tube having a number oflongitudinally extending slits) or a wire basket/expandable braidexpandable element 16A as shown in FIG. 3. Also, kink 32 could bereplaced by other types of a engagement sleeve-deforming structure, suchas a ball or ring of material positioned along locking region 30.

Catheter/Dilator Assembly and Method

Another aspect of this invention is particularly adapted to the removalof blockages or particulate (matter) in hollow tissues. This aspectcombines a catheter having a blocking feature that block the annulusbetween the catheter and the vessel or other hollow tissue. Saidcatheter may have an inner support wire having an occlusion-engagingelement also.

Said support wire extends through the catheter, through or around theocclusion, and at its distal end has an annular braided element attachedthereto or a malecot style element with two or more slits in a tube. Thesupport wire is a dual element support wire having a core and an annularshell that slides on the core. The distal end of the core is attached tothe distal end of the annular braided element (or slit-tube/malecot) andthe distal end of the shell is attached to the proximal end of theannular braided element (or slit-tube/malecot). Thus movement of thecore and shell relative to one another moves the braided element from aradially retracted position, which is useful for insertion through thecatheter to a radially expanded position, which expands it to thesidewall of the graft. When the annular engaging element is in itsradially compressed state, it can be passed through or around theocclusion together with the rest of the wire to reside on the distal endof the occlusion. When the engaging element is expanded and movedproximally (that is, in a retrograde fashion), it will engage theocclusion and force the occlusion into the catheter. Alternatively, nomotion of the engaging element may be required if aspiration is applied.Further, aspiration and proximal motion of the engaging element may beused together in a synergistic fashion to remove the occlusion.

The distal end of the catheter is proximal of the occlusion and containsa blocking mechanism that extends radially from the distal end of thecatheter to the wall of the graft or body passageway. Thiscatheter-blocking element also has a radially retracted insertion stateand a radially expanded blocking state. The blocking element is amulti-wing malecot type device, which may be covered by a thinelastomeric film or membrane. An alternative design of the blockingelement is a mechanism of tubular mesh braid, which may be covered aswell.

This malecot (or the mechanism of tubular mesh braid) is bonded to thedistal end of the catheter or an integral part of the catheter. Theblocking element (or the engaging element for that matter) is deployedin several different ways: 1.) The distal tip of the dilator, over whichthe catheter is inserted, has a slightly increased diameter. This tip isin the nature of a ferrule. When the dilator is removed or pulled in aretrograde (out of the body), the ferrule abuts against the distal endof the multi-wing malecot (or tubular mesh braid) pushing this blockingelement from its radially compressed state into its radially expandedstate. 2.) Alternatively, the tip of the dilator can be bonded to thecatheter with a breakaway bond so that when the dilator is removed, theblocking element is expanded in a similar fashion. In this radiallyexpanded state, the malecot (or tubular mesh braid) and its film cover(if required) blocks the annulus around the catheter so that theoccluded blood, emboli, plaque or other obstruction which is beingremoved is forced into the catheter where it is aspirated, obliteratedor otherwise removed. 3.) Further, both the blocking element or theengaging element could be formed of such materials that have a memoryand hence are self-expanding. These materials are varied from polymersto metals including, but certainly not limited to: PEBAX, nylons,polyurethanes, polyethylenes (HDPE, UHWPE, LDPE, or any blend of theaforementioned polyethylenes), PET, NiTi, MYLAR, (Nickel Titanium Alloy;with or without TWSM (Two Way Shape Memory or superelastic properties).In the case of self-expanding blocking or engaging elements, the larger,expanded configuration could be constrained by an outer tube to keep itin a smaller unexpanded configuration; alternatively an inner supportmember could be used to keep the elements in the smaller unexpandedconfiguration. 4.) Even further, both the blocking and engaging elementscan be deployed by moving two slidable elongated elements with respectto one another. This motion of the two slidable elements would cause theblocking or engaging element to become expanded and/or unexpanded.

Dilator Recess

Another aspect of the instant invention is related to the expandingmechanism on the blocking or engaging element, but likely more pertinentto that of the blocking element on the catheter or tubular device. Thisaspect is related to decreasing the space required for placement of theblocking element in the un-deployed, unexpanded condition. In the casewhere a percutaneous entry is made into a hollow organ, the most commonapproach to entry is a technique known as ‘dilation’ or morespecifically the ‘Seldinger Approach’ to dilatation (after a Dr.Seldinger in the mid 1900's). This is where the interventionalist uses aneedle to enter the body, then a guidewire is placed through the needleand the needle is removed as stated above. Then an assembly known as adilator/sheath assembly is inserted over the guide wire and into thebody. The dilator/sheath assembly is made up of an inner dilator with ahole though the middle of the usually somewhat solid cylindricaldilatory for inserting the guidewire there through. The dilator istapered like a cone usually on a small degree taper approximately 4-20degrees. The sheath consists of a thin walled tube usually made fromPTFE, FEP, polyurethane, PEBAX or similar material and fits snugly overthe inner dilator. Conventionally, once the physician dilates into thebody, the inner dilator is removed so that the physician has access tothe body thorough the thin walled dilatory (0.004-0.018 inches thick).How this relates to the instant invention is interesting in that theinner dilator usually tends to be somewhat ‘solid’ in it's cylindricalconfiguration, but it can have a recess or groove in the cylindricalportion of the dilator for a certain portion of the dilator usuallylocated near the distal end of the device. This recess or groove is aconvenient place for the expanding blocking (or engaging for thatmatter) element to rest in while the device is being placed within thebody. This placement of the blocking or engaging element for that matterallows more material to be placed in the device without increasing theoverall diameter of the device which is particularly important so thatthe physician does not have to make an access site/puncture/hole intothe body larger than what is absolutely necessary. This dilator may havea lumen with a side port to enable the monorail configuration describedbelow under Rapid Exchange. A long dilator configuration can be used tosupport devices traversing vessels spanning the length of the humanbody. By incorporating the monorail feature, the dilator can be removedfrom a device and guidewire that is only slightly longer than thedilator shaft.

FIGS. 4-18A illustrate novel method and apparatus in conjunction with anexemplary thromboectomy procedure. FIG. 4 illustrates a needle 36inserted into a graft 38, or other tubular structures such as a bloodvessel, having an occlusion 40 within a lumen 42. An expandable elementguide wire 10 is shown in FIG. 5 passing into lumen 42 with the aid ofneedle 36 with expandable element 16, in a radially contracted state,positioned distally of occlusion 40. FIG. 6 illustrates expandableelement 16 placed in a radially expanded state by pulling on deploymentgrip 26. FIG. 7 illustrates removal of needle 36 while leaving guidewire 10 in place.

FIG. 8 illustrates a recessed dilator 46 to be used with the funnelcatheter assembly 48 of FIG. 9. Dilator 46 includes a hollow shaft 50having a fitting 52 at a proximal shaft end 54 and a recess 56 at adistal shaft end 58. Shaft 50 terminates at a tip 59.

FIGS. 9, 9A and 10 illustrate funnel catheter assembly 48 to include acatheter 60 extending from a proximal catheter end 62 to a distalcatheter end 64. A radially collapsible funnel element 66 extends fromdistal catheter end 64. Funnel element 66 is preferably a braided funnelelement having a normally radially expanded state, shown in solid linesin FIG. 9, and a radially collapsed state, shown in dashed lines in FIG.9. Funnel element 66 has an axial length 68 in its radially collapsedstate. Funnel catheter assembly 48 also includes a compression sleeve 70and a split stopper sleeve 72, both slidably mounted on catheter 60.Split stopper sleeve 72 is also illustrate in FIG. 10 and has a cutawayproximal sleeve portion 74 and a weakened region 76, the purpose forwhich will be discussed below. Catheter 60 has a lumen 78, see FIG. 9A,for receipt of hollow shaft 50. Proximal catheter end 62 has a port 80connected to a tube 82 with a fitting 84 at the end of the tube. Thispermits fluid or other flowable material to be directed through lumen78.

FIG. 11 illustrates a user inserting tip 60 of shaft 50 of recesseddilator 46 into proximal catheter end 62 of funnel catheter assembly 48.A tube clamp 86 is shown mounted along tube 82. FIG. 12 illustratesrecessed dilator 46 fully inserted into funnel catheter assembly 48 tocreate a funnel catheter/dilator subassembly 88. Funnel element 66 isshown aligned with and overlying recess 56 with the user preparing toslide compression sleeve 70 in the direction of arrow 90. FIG. 13 showscompression sleeve 70 fully covering funnel element 66 and leaving aportion of catheter 60 between the compression sleeve and split stoppersleeve 72 exposed. The provision of recess 56 and the alignment offunnel 66 with recess 56 help to minimize the outside diameter ofsubassembly 88, thus helping to minimize patient trauma.

FIG. 14 illustrates a tearaway sleeve 92 used with subassembly 88 tocreate the catheter/dilator assembly 94 of FIG. 15. Sleeve 92 has asmaller diameter distal portion 95 and a larger diameter proximalportion 96. The inside diameter 98 of distal portion 95 is sized to fitsnugly over distal shaft end 58 of shaft 50 and funnel 66 within recess56. Inside diameter 100 of proximal portion 96 is sized to fit snuglyover catheter 60. Therefore, sliding sleeve and a proximal direction,that is in the direction of arrow 102 as shown in FIG. 15, causesproximal portion end 96 to contact compression sleeve 70 and initiallydrive compression sleeve 70, and then both compression sleeve 70 andsplit stopper sleeve 72, in a proximal direction until the junction 104,see FIG. 14A, between distal and proximal portions 95, 96 of sleeve 92generally abuts distal catheter end 64 of catheter 60. The proximalmovement of split stopper sleeve 72 is accommodated by proximal sleeveportion 74 deforming and/or deflecting as illustrated in FIG. 15. Theoutside diameter of distal portion 95 is about equal to the insidediameter 100 of proximal portion 96.

FIG. 16 illustrates catheter/dilator assembly 94 mounted over expandableelement guide wire 10, see FIG. 7, with tip 59 positioned proximally ofocclusion 40. It is preferred that the junction 104 remains outside ofgraft 38 to minimize the size of the access opening in the graft throughwhich tip 59 passes. To permit funnel element 66 to expand, tearawaysleeve 92 is pulled proximally as indicated by arrows 106; becauseinside diameter 98 is smaller than the outside diameter of catheter 60,this movement is accommodated by a weakened region 108, see FIG. 14, ofdistal portion 95 of sleeve 92 splitting open. It is preferred that thetip 110 of distal portion 95 not split open so to accommodate any futuremanipulation of the assembly. This movement also causes split stoppersleeve 72 to tear along weakened region 76 thus permitting sleeve 72 tobe completely removed from the apparatus. To remove occlusion 40, theuser may pull on guide wire 10 causing expandable element 38 to driveocclusion 40 towards funnel 66; a suction force may be created in tube82, typically using a vacuum syringe attached to fitting 84, and thus ina vacuum space 112 created between distal catheter end 64 and shaft 50as shown in FIG. 18A. Depending upon the composition of occlusion 40,the occlusion may be drawn completely into tube 82. Tube 82 may besufficiently transparent or translucent to allow the presence of theremains of occlusion 40 to the visually observed by the user within thetube.

Rapid Exchange

Another aspect of the invention relates to designs that provide for themanufacture and function of the matter removal system. One such aspecthas been often referred to as a ‘Rapid Exchange’ or ‘Mono Rail’ feature.This common feature is usually used for elongated catheters when used inconjunction with guide wires (AKA wire guides). Usually aninterventionalist inserts a guidewire into the body via an existingopening or through a percutaneous opening often created by a needle. Theguidewire, because it is a small wire, is easier to manipulate intoposition than would be a catheter or other elongated device. Once inplace the interventionalist usually inserts the elongated catheter orother device over the guidewire to the appropriate position hence thereason for the name guide wire. Before the development of Rapid Exchangeor Mono Rail techniques, the interventionalist would need to use a guidewire that was more than twice the length of the elongated catheter ordevice so that the device could be inserted over the wire outside of thebody while the guidewire stayed in place in the appropriate positionwithin the body. This ‘double length feature’ provided theinterventionalist the safety of inserting the device over the guidewireand at the same time holding the guidewire in place so that it does notmove from the desired location within the body. This technique wascumbersome because of the double length of the guidewire. The RapidExchange or Mono Rail technique provide for a small hole at the distalend of the catheter or device with that hole/lumen exiting the catheteror device a short distance from the distal end, usually approximating3-12 (7.6-30 cm) inches from the distal end of the device.

This aspect of the invention is a variation of the Rapid Exchangefeature. A dilator is used within the tubular catheter or device of theinstant invention whereby the dilator has the feature of having an holefrom or near the distal end and then exiting some 3-12 inches from thedistal end, but instead of sliding the catheter or device of the instantinvention ‘over’ the guidewire, the guide wire is loaded in place insidethe dilator which is inside the tubular elongate lumen of the instantinvention. When the assembly gets near the trouble area in the body tobe intervened, the interventionalist would then be able to steer thewire from within the dilator, but outside of the body. This allows thesimilar feature of the aforementioned Rapid Exchange or Mono Railtechnique. When the interventionalist is near the area to be treated,he/she can remove the inner dilator leaving the inner guidewire in placeand hence obviating the need for a double length guidewire.

FIGS. 19-22 illustrate a rapid exchange dilator assembly 116 comprisinga catheter 118 having a distal catheter end 120 and a proximal catheterend 122. Catheter 118 includes an outer catheter 124 and an innercatheter 126 slidably housed within the outer catheter. Outer catheter124 includes an outer catheter fitting 130, fitting 130 including aconventional sealing element 132 to create a fluid seal between outercatheter 124 and a proximal portion 134 of inner catheter 126. Whileouter and inner catheters 124, 126 are preferably flexible along most oftheir lengths, proximal portion 134 of inner catheter 126 and theproximal portion 136 of outer catheter 124 are both preferably made ofmetal tubing Inner catheter 126 also includes an inner catheter fitting138 having a fluid port 140 opening into a catheter lumen 142 ofcatheter 118.

Assembly 116 also includes a dilator 144, having a distal portion 146and a proximal portion 148, and a guide wire 150 extending generallyparallel to dilator 144. In the assembled configuration of FIGS. 19-22,guide wire 150 has a tip 152 extending beyond dilator tip 154 and aguide wire proximal end 156 extending through and past inner catheterfitting 138. Proximal portion 148 of dilator 144 has a relatively smalldiameter to provide sufficient room for the passage of guide wire 150through catheter lumen 142 as shown in FIG. 21. However, it is desiredto minimize the diameter of catheter 118 and also have guide wire 150pass through the dilator lumen 158 at dilator tip 154. Therefore, aguide wire pathway in the form of a groove 160 is formed along dilator144 to accommodate guide wire 150. Towards dilator tip 154, such asabout 15 cm from tip 154, an opening 162 is formed in dilator 144coupling groove 160 and dilator lumen 158 to permit guide wire 150 topass along groove 160, through opening 162, along lumen 158 and outthrough dilator tip 154. See FIG. 20. The guide wire pathway may also becreated by a lumen formed in dilator 144 or by a separate tubularelement mounted to the dilator.

Catheter 118 also includes an expandable braid 164 connected to thedistal ends of outer and inner catheters 124, 126. Pulling innercatheter fitting 138 relative to outer catheter fitting 130 causes braid164 to expand. While braid 164 may expand in a manner similar to thatshown in FIGS. 1 and 2, it may also expand to create a funnel-typematerial-directing element as shown in FIGS. 9 and 12, discussed above,or in FIGS. 29-54, discussed below Inner catheter fitting 138 alsoincludes a dilator/guide wire seal element 166 permitting a seal to becreated between proximal portion 134 of inner catheter 126 and proximalportion 148 of dilator 144.

FIG. 23-28 will be used to describe an exemplary use of rapid exchangedilator assembly 116. FIG. 23 illustrates a heart 170 including a bypassgraft 172 connecting the ascending aorta 174 with a coronary artery 176.FIG. 24 illustrates the passage of the first guide wire 178 throughascending aorta 174 and into bypass graft 172 with the tip 180 of firstguide wire 178 positions near, in this example, a lesion 182. Guide wire178 is typically a large, such as 0.038 in. diameter, guide wirecommonly used to help the physician to get to the general vicinity ofthe treatment site. Thereafter, as shown in FIG. 25, a conventionalguide catheter 184, typically 7 French or 8 French in size, ispositioned using first guide wire 178. Next, first guide wire 178 isremoved leaving guide catheter 184 in position. This permits the distalportion of rapid exchange dilator assembly 116 to be passed throughguide catheter 184 until expandable braid 184 extends past the distalend 186 of guide catheter 184 as shown in FIG. 26. Guide wire 150 isthen extended to a chosen position relative to lesion 182 as shown inFIG. 27.

Dilator 144 is then removed by pulling on dilator proximal portion 148while holding inner catheter fitting 138 and proximal end 156 of guidewire 150. Doing so leaves catheter 118 and guide wire 156 in place. Thisis possible because of the rapid exchange nature of assembly 116provided by the passage of guide wire 150 externally of most of thelength of dilator 144. The expandable braid 164 may then be extended toa use, material-directing state, such as the funnel shape shown in FIG.28, to occlude blood flow to stop emboli from flowing downstream.Appropriate medical procedures, such as installing a stent or conductingangioplasty may then the accomplished.

RF Bonding

A further aspect of the invention relates to devices and methods formanufacturing thermoplastic materials. As the name thermoplasticimplies, temperature can be used to shape, make, bend, mold, join, tip,bond, shape polymers (or metal to polymers) for use in production ofcomponents or other products. There is a plethora of techniques wellknown to those ordinarily skilled in the art of ‘plastics manipulation’using heat to change the physical shape or properties of the plasticmaterial. Injection, plug, insert, blow molding as well as heatingtubes, hot water or other liquids, flame, heat guns, heat shrink tubingand other technologies too numerous to mention.

This aspect of the invention utilizes a constant temperature alloy thatcan be near instantly brought to a particular curie temperature. Thepresent invention employs a temperature self regulating heater, withregulation of temperature being accomplished by employing a high densitymaterial such as a ferromagnetic, ferromagnetic or the like materialhaving a Curie temperature at the desired maximum temperature ofoperation. The Curie point also known, as Curie temperature is thepoint/temperature at which a ferromagnetic material exhibitsparamagnetism. Once this point is achieved, no additional energy isrequired to be put into the system and the temperature (Curietemperature) is maintained. This pre-chosen temperature can be set at avariety of temperatures depending on the chemical makeup of theferromagnetic material and this choice can match the melt or near melttemperature of a particular plastic.

To be able to control a heating element for manufacturing/production ofthermoplastic materials that does not require a temperature feedbackloop to control the temperature of the particular element/die or othermechanism is desirable for several reasons. This aspect of the inventionuses a ferromagnetic metal with low electrical conductivity that can beexcited by a high frequency alternating current. By selecting dimensionsand material parameters for the heating element, temperature regulationin a narrow range around the Curie temperature of the ferromagneticmaterial can be produced, despite thermal load (i.e. the melting or nearmelting of plastic).

This therefore does not require a conventional feedback loop (andrequired controllers and no necessary calibration) to control thetemperature of the heating element. Specific ferromagnetic materials canbe chosen that reach particular Curie temperatures, so that choosing aparticular ferromagnetic material for the heating element with aparticular Curie temperature for a particular application can choose atemperature. This allows a narrow range of temperatures to be achieved.Because the mechanism of use for the excitation of the ferromagneticelement is instantaneous with the alternating current source, theferromagnetic material/element comes to its pre-destined Curietemperature very quickly. This instantaneous heat source is vital informing thermoplastics quickly for efficient manufacturing conditionsand a low cost manufacturing environment.

In brief, one embodiment of the present invention is particularlyadapted to the manipulating thermoplastic materials with a die/element,mold (“heater”) for manufacturing of components or other products in themanufacturing environment. By purchasing an ‘off the shelf’ RFgenerator/alternating current power source, one can excite aferromagnetic heater to its Curie temperature and then by choosing aparticular ferromagnetic alloy, different temperatures can be used forthe heater in the manufacture/processing of particular thermoplasticmaterials.

Examples of ferromagnetic materials that exhibit different Curietemperatures when excited by an alternating radio frequency source is ametal alloy composed of approximately 36% nickel and the balance iron.Often referred to as Invar or Alloy 36 due to the nickel content. Whenalloy 36 is excited to it's Curie temperature, that temperature iscontrolled to a near temperature of .about.230 degrees Fahrenheit.(.about.230.degree. F. or 110.degree. C.). Choosing alloy 42 (meaning.about.42% nickel and the remaining iron), the Curie temperatureachieved is .about.380.degree. F. or 193.degree. C. For alloy 49, atemperature of .about.475.degree. F. or 246.degree. C. For alloy 32,approximately 130.degree. F. or 54.degree. C. For alloy 34, 165.degree.F. or 74.degree. C. and for alloy 42-6, 290.degree. F. or 143.degree. C.So one can see that by choosing a particular ferromagnetic alloy, onecan choose a particular melt or near melt temperature of a particularthermoplastic. Such ferromagnetic materials can be readily purchasedfrom a wide variety of vendors including SCIENTIFIC ALLOYS in Westerly,R.I. ((401) 596-4947).

By connecting the power supply to the alloy though a trial and errorapproach the alloy became excited to its particular Curie temperatureand was measured. These temperatures were delineated above. By machiningdifferent configurations in the heater element, the inventor was able tojoin thermoplastic materials with a variety of other materials (metals,thermoplastics, Thermoset polymers, fabrics and the like). Further, theinventor was able to form or program the thermoplastic material intowhat appears to be an endless variety of shapes and conditions for use.

Another aspect of the invention pertains to the engaging or blockingelement. In the case where either element is somehow bonded to a tubularelongate member, this bond should be strong, but minimal in its overallsize. In the case of using tubular mesh braid to attach the mechanism tothe tube, often times an additional collar can be used to overlap boththe tubular elongate member and the tubular mesh braid. However thisaspect of the invention allows this ‘joint’ to be accomplished byjoining the two components together without the addition of this collar,which is preferred because in such interventions any additional spacerequired for ‘joints’ is a detriment to the overall functionality of thedevice. If collars or other assembly mechanisms are used either on theoutside of the two materials or on the inside of the materials, either alarger hole/puncture into the body is required, which has an increasedmortality/morbidity associated with it, or the internal diameter of thetubular elongate member is decreased, and hence the annular space isdecreased and compromised because the interventionalist has less spaceto deliver other instruments or less space to remove matter from thebody. Hence this aspect of the invention relates to the ability to‘connect’ the tubular mesh braid to the tubular section of the catheteror device and at the same time minimizing any increased wall thicknessdue to collars or other assembly components. This can be accomplished inseveral ways.

In most cases the wall of the tubular elongate member is in the range of0.002-0.015 inches (0.051-0.38 mm) thick, but more usually in the0.004-0.006 (0.10-0.15 mm) inches thick range. Because of the way it ismanufactured (with a Maypole type braider described below), the yarnsused to manufacture the tubular mesh braid are usually fabricated fromfilaments in the range of 0.0001 to 0.005 inches (0.0025-0.13 mm) indiameter, but more usually in the 0.0015-0.003 inch (0.038-0.076 mm)diameter range. Because these individual yarns overlap, the wallthickness of the tubular mesh braid is usually double the thickness ofthe yarns used in its manufacture. The instant invention relates to thefact that the tubular mesh braid can be melted into the wall of thetubular elongate member with the use of heat. This is especiallyapplicable when thermoplastic polymers are used with either one or bothof the tubular mesh braid or the tubular elongate member. Using a diethat conforms to the outside diameter of the tubular elongate member,both materials can be forced into the die when heat is applied and atthe same time an inner mandril is placed inside the assembly that equalsthe internal diameter of the tubular elongate member. Using then theheat and force, the two components (the tubular mesh braid and thetubular elongate member) can meld into one unit thus minimizing the wallthickness of the two components thusly joined together. This heated dieis usually accomplished using a glass or metal die. Heat is applied tothe die in any of a number of ways know those normally skilled in theart including, but not limited to convection heating, electricalresistance heating, RF excitement of the metal to create heat, by merelyblowing hot air over the die, etc.

A preferred embodiment of the instant invention utilizes an RF heatermade from an RF power supply and a nickel iron alloy. By coordinatingthe radio-frequency (RF) energy with an appropriate nickel-iron alloydie, the metal alloy die can be excited by the radio-frequency energy,said excitement generating heat to the curie temperature of the alloy.The blend of nickel-iron alloy can be adjusted to reach different curietemperatures. This RF excitement is extremely fast which is critical tothe efficacious manufacture of the devices. The dies can be made verysmall, that is with a very small amount of alloy, so that they not onlyheat up immediately, but they can be cooled quickly as well. Hence theless alloy in the die the faster the throughput in the manufacturingprocess. This technique is extremely repeatable as well due to therepeatability of the RF and the alloy interaction. These differenttemperatures are important as different temperatures are required fordifferent heat bonding procedures (that are dependent both on thegeometrical configuration of the heat bond as well as the materials usedin the heat bond). Using this configuration, expanding mechanismsdescribed above have been manufactured where in a preferred embodimentof the instant invention, NiTi (Nickel Titanium) tubular mesh braid with0.003″ (0.076 mm) individual yarns have been melded into the wall ofPEBAX and polyurethane sheath tubes that have a wall thickness of0.005-0.006″ (0.13-0.15 mm) without compromising the internal orexternal diameters. (Have also melded 0.002″ (0.051 mm) diameter yarnsinto both polyethylene and FEP). Because no extra material is used forthis bond and no additional area is required to make this bond this isextremely important so as to allow more matter to be removed through theinternal diameter (being optimized and not decreased or compromised) andthe initial puncture into the body is minimal due to theminimized/optimized external diameter of the assembly as is furtherdescribed below and herewith.

Braid Shapes with Heat Treating and Elastomer (Variable Vessel Diameter)

Another aspect of the invention pertains to a funnel manufactured usingtubular mesh braid. In a preferred embodiment the funnel is made of theaforementioned tubular mesh braid. In particular, the yarns in the braidare made of metal and even more particularly, of Nickel Titanium alloy(NiTi). The preferred embodiment of this aspect of the invention is suchthat the tubular mesh braid is attached to an inner elongate member onthe distal end and an outer elongate tubular member where the braid isattached at the proximal end. As the inner member is pulled in aretrograde/proximal direction, the braid is pulled inward so that itbuckles, and folds inside itself like ‘rolling a sock’. In thispreferred embodiment, the braid takes on a funnel shape. In some casesthe braid is covered with an inelastic or elastic membrane. Thismembrane can be applied by dipping, casting or spraying the braid with adispersion including, but not limited to silicone or polyurethane.Alternatively, the membrane could be in the form of a tubular extrusion,which is then bonded with heat, or adhesive on the two (proximal anddistal) ends of the braid where it is attached to the inner and outerelongate member. In the case of using the extrusion, this materialincludes, but is not limited to silicone, polyurethane, Chronoprene,polyethylene, C-Flex, etc.

Of particular importance to the design of the tubular mesh braid is theway in which the tubular mesh braid is formed. The preferred embodimentof the instant invention forms the tubular mesh braid on a maypolebraider described below using 48 carriers of yarns made from NiTi on a48 carrier or 96 carrier maypole braider, although in some instances itmay be beneficial to use machines with more or fewer yarn carriers toadjust braid performance The NiTi yarns used are small in diameter, inthe range of 0.001-0.005 inches (0.025-0.13 mm) in diameter, but morespecifically 0.0015-0.0025 inches (0.038-0.064 mm) in diameter. They canbe formed on a cylindrical mandril on the braider usually 5-6 mm indiameter or more preferred would be a conically shaped mandril to createa mesh braid with varying wire density and varying maximum expandeddiameter to facilitate funnel deployment in lumens of various sizes. Infact, the mandril shape can be set to any axisymetric shape (forinstance, a rotated parabolic arc) to further optimize the performanceof the expanding member. In some cases, a non axisymmetric shapedmandril may be used as well, such as an elliptical cone or a pyramid.Further, the tubular mesh braid could be self-expanding where the yarnsare programmed to be in the expanded funnel configuration. In thisembodiment, the system could be constrained with an over sheath to keepin the smaller, contracted condition. Conversely, the inner and outerelongate members could be held in a tensile configuration with respectto one another so that the braid is in the un-expanded shape. When thetension is removed on the inner and out elongate member, the braidexpands to the funnel configuration usually 1.5-7 mm in diameter, butmore specifically from 2.5-5.5 mm. In addition, any combination ofactive or forced expansion and self-expansion may be used to optimizethe design.

An additional aspect of the invention as it pertains to how the braidopens up into a funnel shape is the way that one ‘programs’ the tubularmesh braid. When the braid is pulled together so that it folds intoitself to make the funnel shape, it may be important that there is ashape memory to the braid so that it folds in a particular way both tocreate the funnel, but also so that when it impinges on the wall of thevessel, it does so in a least traumatic fashion so as not too damage theintima of the vessel. The NiTi wires are preferably conditioned as tobehave as super-elastic or pseudo-elastic material. In the case ofexpanding the funnel and trying to occlude blood, it is important isthat the funnel has an outward radial force onto the vessel so that itin fact occludes the vessel and stops blood flow. This is important inthe case of using the invention for ‘proximal occlusion’.

Proximal occlusion, as the name indicates, is where the blood vessel isoccluded proximally (up-stream) to where an intervention takes place(i.e. balloon angioplasty, stenting etc.). When the flow is stopped orreduced upstream to where the intervention is taking place, thisprevents loose embolic material that may be dislodged from travelingdownstream during the intervention. This dislodged emboli can be verydangerous and even cause stroke or in the worse case death.

By shaping the braid by braiding/winding it on a shaped mandril such asa tapered mandril or a mandril with various shapes on it, one can affectdifferent characteristics of the tubular mesh braid. Braiding over amandril tool of varying diameter with constant braiding machine speedvaries the pitch of the braid and number of crossings over a givenlength of braid. Varying these parameters along a single braidedcomponent helps dictate where the braid will first collapse to then workas a “rolling sock”. Further, heat-treating to modify the material orbraid shape has positive effects as well. One may alter the materialproperties of the braid only in certain parts of it so that gradients ofstiffness are present along the length of the braid. These changes instiffness may be extremely rapid to incite buckling (funnel formation)at a particular location or actuation force, or may be gradual toprevent buckling and perhaps maintain radial force. This allows thebraid to fold, and to form a funnel in a particular fashion as it isbeing deployed. Additionally, by heat-treating the braid in such a wayso as to effect a geometrical change, the braid will tend to fold/rollin a desired way so that the deployed braid/funnel occludes properlywith the desired amount of radial force and at the same time expands toa desired diameter and shape, as well as expanding in an a traumaticfashion. For instance, a shape step may be formed into the braid wire sothat upon actuation, the distal portion of the braid extends radiallyout to make contact with the vessel wall creating a deployment shapethat is conducive to braid buckling. The size and geometry of this stepcan be adjusted to a particular application. Any sort of geometricalchange can be formed during the actual braiding process, or throughsecondary mechanical or thermal means at any time in the manufacturingprocess.

Another secondary operation that may be used to improve the performanceof the expanding braid section is the inversion of the braid. By turningthe mesh braid “inside out”, it exhibits properties different from thoseof a “right side out” braid section. These differences may be greatestwhen the braid wire material is nitinol, and it is inverted after heattreatment, but some desirable performance characteristics may be presentwhen using other braid wire materials, such as stainless steel, or wheninverting the braid without heat treatment.

As previously mentioned, the overall profile of the device is ofcritical importance so that the physician can use the smallest incisionnecessary while still having the largest size lumen available for othertherapeutic devices. With this in mind, another preferred designembodiment employs a braided shaft with an integral expanding braidsection at the distal end. The braided shaft can be constructed with thedesired wall thickness (specifically between 0.002″ and 0.015″(0.051-0.38 mm)) and stiffness characteristics, and the expanding braidportions can be formed by simply continuing the braid beyond the shaft'spolymer components. This process eliminates any secondary bond betweenthe expanding braid and the shaft, and simultaneously creates a devicethat is stronger and more durable. One of many possible manufacturingmethods entails placing the polymeric inner liner of the braided shafton a mandril, and loading the mandril and liner assembly through themaypole braider. The mandril may have a distal shaped section that canbe used to form the desired expanding braid shape. Braiding is continuedover the expanding braid section of the mandril, and heat-treated ifnecessary. The outer polymeric component, or components are thenlaminated over the braided shaft section.

Using different coverings over the tubular mesh braid as well can modifyall of these characteristics. For example, one embodiment of theinvention would be a thermoplastic extrusion that has variable wallthickness. The wall thickness of the membrane may be varied along thelength of the braid to have one or more zones of increased or decreasedresistance to actuation (expansion), or zones of increased durability.These variable wall thicknesses will also allow the thinnest sections ofthe tubular mesh braid to expand first or to a larger overall diameterin contrast with zones having thicker membrane thicknesses. Theadjustment of the order or degree of actuation of various sections alongthe length of the expanding braid will allow the device to achieve anoptimum balance of actuation reliability, actuation force, and radialforce exerted on the vessel wall. Generally, an extruder can extrude toapproximately 0.003″ (0.076 mm) wall thickness of the tubing. In themanufacturing process, the technician can ‘pre-dilate’ the extrusion(all or part) and in doing so can controllably change and vary theexpansion properties and wall thickness to achieve better deviceperformance as compared to pre-dilated membranes. The easiest way toaccomplish this ‘pre-dilation’ is to apply air pressure to the extrusionwhen it is sealed off at one end. Most thermoplastic elastomers used forthis application have elastic modulus characteristics from 300-1500%,but more particularly from 600-1000%. Examples such as Chronoprene,polyurethane, C-Flex, latex, polyisoprene and silicone exhibit theseproperties.

FIG. 29 illustrates the distal end of a funnel catheter 190 including anouter tube 192 having a distal tip 194, an inner tube 196 having adistal tip 198 and a tubular sleeve 200 having first and second ends202, 204 secured to distal tips 194, 196. Tubular sleeve 200 is shown inits radially contracted, deployment state. It is important that tubularsleeve 200 have a generally U-shaped, direction-reversing region 206 sothat when first and second ends 202, 204 move toward one another fromtheir positions of FIG. 29, sleeve 200 moves to a distally opening,radially expanded, use state, such as shown in FIG. 31. FIG. 30illustrates an alternative embodiment of funnel catheter 190 in whichregion 206 in the deployment state has a more pronounced U-shape thanthe embodiment of FIG. 29. FIG. 31 illustrates funnel catheter 190 in aradially expanded use state. Funnel catheter 190 is typically used toseal the interior of a graft, blood vessel or other hollow bodystructure so that the material from which funnel catheter 200 is made istypically substantially impervious to fluid flow. While tubular sleeve200 is preferably a braided tubular sleeve impregnated with a flexiblepolymer material, sleeve 200 maybe constructed in other ways. FIG. 32illustrates a tubular sleeve 200 and which the fluid flow barrier isprovided as a flexible, elastic film 208 on the outside of tubularsleeve 200. FIGS. 33 and 34 illustrate placement and use of funnelcatheter 190 within a vessel 210. Pulling inner tube 196 relative toouter tube 198 causes tubular sleeve 200 to create a funnel-typematerial-directing element with a substantial portion 212 contacting theinner wall 214 of vessel 210. Funnel catheter 190 can be made to providea sufficiently high level of force to inner wall 214 over a relativelylarge contact area to provide a good seal while minimizing risk oftissue damage.

Other methods to achieve a funnel catheter that reliably creates adistally directed open funnel end will be described below with referenceto FIGS. 35-51. In general, the different techniques include adjustingthe taper angles at the distal and proximal portions of the mandril,selectively applying material to one or both of the distal and proximalportions of the braided material, and changing the pic count between thedistal and proximal portions. While in practice more than one of thesetechniques may be used to construct a working device, the differenttechniques will be discussed below with regard to specific embodimentsincorporating a single technique.

FIG. 35 illustrates a mandril 218 having a proximal taper portion 220and a distal taper portion 222 connected by a central, typicallyconstant diameter, portion 224. Mandril 218 is wound in a braidedfashion with braid winding 226 to create a braided structure 228.Proximal taper portion 220 has a more gradual paper than distal taperportion 222, that is .theta.sub.1>.theta.sub.2. In the embodiment ofFIG. 35, the pic count, that is the number of crossings of braidwindings 226 per unit length, is constant along the entire length ofmandril 218. A membrane, not shown, may be used with braided structure228. The membrane maybe incorporated into, lie on top of or be locatedwithin braided structure 228. The membrane may be chosen to halt allfluid flow therethrough or only prevent the passage of particles havinga minimum size. Braided structure 228 is then removed from mandril 218and mounted to outer and inner tubes 230, 232 to create a funnelcatheter 234 with a tubular braided sleeve 236. See FIGS. 36-39.

The proximal end 238 of sleeve 236 is secured to a first position 240 onouter tube 230 and the distal end 242 of sleeve 236 is secured to asecond position 244 on inner tube 232. The greater taper at distal taperportion 222, .theta.sub.1>.theta.sub.2, helps to ensure that the distalportion 246 of sleeve 236 buckles before the proximal portion 248 of thesleeve. See FIGS. 38 and 39. While inner tube 232 is shown extendingdistally an indeterminate distance, it may be, for example, terminatedat or near second position 244 on inner tube 232.

FIG. 36 illustrates tubular braided sleeve 236 in a larger diametervessel 250. As the vessel diameter is increased, the contact length ofthe braid is reduced. This makes the distal/proximal competition moreimportant (the distal portion 246 of sleeve 236 must buckle first)because friction between the device and the vessel wall does notsignificantly help to create the distal funnel. With smaller diametervessels 254, see FIGS. 37 and 39, outer tube 230 is typically held fixedwhile inner tube 232 is pulled proximally. Friction between braidedsleeve 236 and vessel 254 helps to hold the proximal, outer tube 230fixed while motion at the distal end 242 of sleeve 236 makes the distalportion 246 of sleeve 236 collapse. With large vessels, see FIGS. 36 and38, the friction is less than with smaller diameter vessels to increasethe possibility that the whole tubular braided sleeve 236 can shift(slide) potentially causing proximal portion 248 of braided sleeve 236to buckle. When the pic count is constant or generally constant as inthe embodiment of FIGS. 35-39, is very important that the difference inthe taper angles provide the necessary bias to ensure that distalportion 246 always wants to yield first (that is, before proximalportion 248) and collapse into a funnel shape as illustrated in FIG. 38.

FIGS. 37 and 39 illustrate tubular braided sleeve 236, having a constantpic count, in smaller diameter vessel 254. In this situation, much ofthe braided sleeve 236 comes in contact with the vessel wall. Providingan appropriate difference in taper angles with.theta.sub.1>.theta.sub.2, ensures that distal portion 246 bucklesbefore proximal portion 248.

FIG. 40 illustrates an alternative embodiment of a constant pic counttubular braided sleeve 236 designed to ensure that distal portion 246buckles before proximal portion 248. Braid windings 226, typically madeof NiTi, at distal end 242 of sleeve 236 are heat-treated to make anabrupt diameter change after braiding. This creates a weak geometry inthe shape at this position so that with the application of a smallcompressive load, sleeve 236 will buckle in the region of distal end242. This effect is made more effective with increased distal end taperangle .theta.sub.1 and a reduced radius at this position. Other methodsfor creating a sharp step shape set in the braid after weaving may alsobe used.

FIG. 41 illustrates a further alternative embodiment of a constant piccount tubular braided sleeve 236 designed to ensure that distal portion246 buckles before proximal portion 248. A part of proximal portion 248is coated with a polymer 256, which is typically somewhat elastic, tolimit expansion of proximal portion 248 so it cannot fully expand andbuckle. The remainder of sleeve 236 is uncoated to promote buckling atdistal portion 246.

FIG. 42 similar to FIG. 41 accuses a relatively stiff, relativelystretch resistant polymer coating 256 at proximal portion 248 and arelatively soft, relatively easily stretched polymer coating 258 atdistal portion 246. Polymer coating 256 keeps the proximal braid fromfully expanding and buckling. The soft distal covering provided bypolymer coating 258 allows full expansion, buckling and a good hydraulicseal to enable aspiration through the center of this device. If desired,the central portion 260 of sleeve 236 may also be covered with the same,soft, easily stretchable polymer 258 for a different polymer that may beeven more easily stretched than polymer 258.

FIGS. 43 and 44 illustrate alternatives to the braided structure 228 ofFIG. 35. FIG. 43 shows a double wire braided structure 262 having aconstant pic count. The double wire can be round or ribbon coming off 1or 2 spools. More wires such as 2, 3, 4 or 5 can be stranded together toallow low bending forces with high hoop strength. This will allow thebraid to have great composite strength with the ability to shift to alow profile and be flexible in a catheter. FIG. 44 illustrates aconstant pic count ribbon band braided structure 264. Structure 264 istypically made of NiTi, stainless steel, titanium, a polymer or tungstenin sizes ranging from 0.0003 to 0.005 inch thick by 0.001 to 0.030 inchwide (0.0076 to 0.13 mm thick by 0.025 to 0.76 mm wide). One examplecould be 0.0005 inch thick by 0.003 inch wide (0.013 mm thick by 0.076mm wide).

FIG. 45 shows an alternative to the constant pic count embodiment ofFIG. 35. Braided structure 266 has a variable pic count with a higherpic count along the proximal taper portion 268 and a lesser pic countalong the distal taper portion 270. Braided structure 266 can beproduced by gradually speeding up the “take up” reel on the braids whilerunning the wire spools at a constant speed. This design can be tuned tomake distal taper portion 270 weaker with large openings (distancebetween wire crossings) so it buckles into a tunnel before the proximaltaper portion 268. This design can accommodate relatively large radialexpansion to cover a large range of vessel sizes. Removing some of thewire strands to create braided structure 272 as shown in FIG. 46 cancreate a similar effect, that is forcing distal buckling before proximalbuckling. The wires are braided a distance over mandril 218, every otherwire is cut (as an example) and then the braiding is continued with alower pic count and fewer number of wires.

A variable pic count funnel catheter 274 is shown in FIG. 47 andincludes a tubular braided sleeve 276 made from braided structure 266 ofFIG. 45. Variable pic funnel catheter 274 is shown partially expanded ina larger diameter vessel 250. Proximal taper portion 268 of braidedstructure 266 can fully expand but the taper is so gradual that itbehaves more coil bound. Distal braid portion 270 must have asufficiently low pic count to be sufficiently weak to yield first.Funnel catheter 274 is shown in FIG. 48 within a smaller diameter vessel254. In this case it is beneficial to have a low pic count distally sodistal taper portion 270 is weaker than proximal taper portion 268 andtends to buckle under compressive load. This works well as long as theproximal end cannot fully expand in the vessel diameter. High pic countsthat cannot fully expand tend to lock up with lots of support (closelyspaced supporting crossings).

The variable pic count braided structure 278 of FIG. 49 reverses thewinding pattern of braided structure 266 of FIG. 45 to provide a higherpic count at distal taper portion 280 than at proximal taper portion282. This can be tuned to allow the smallest section of distal taperportion 280 to fully expand before hitting the vessel wall, or even thesmallest anticipated vessel size. At full expansion, the windings 226 ofvariable pic count funnel catheter 284, see FIGS. 50 and 51, at distalend 242 are pushed into nearly a coil bound hoop path that can easilybuckle to create the distal funnel before the proximal end buckles.After the initial buckling, the distal funnel end can grow like arolling sock as distal and proximal ends 242, 230 move towards oneanother to enlarge the funnel opening. FIG. 48 illustrates funnelcatheter 284 within smaller diameter vessel 252. The high pic count atthe distal portion of braided structure 286 causes the distal portion tobuckle first as long as it can fully expand in the vessel. The higherthe pic count of a section of tubular braided structure 278 on themandril, the less that section will expand under axial compression. Thesection of structure 278 having a very high pic count will remain almostfully expanded in the low profile catheter. After actuating, the veryhigh pic count section will become hoop-like and buckle.

A Balloon that is a Funnel

Another aspect of the invention relates to a funnel shaped balloon. Thisis easily accomplished by shaping the balloon in such a way so that whenit is expanded by gas or liquid, it expands in the shape of a funnel.This can be accomplished in several ways. In the case of making aballoon from a thermoplastic material including, but not limited toChronoprene, polyurethane, C-Flex, Latex rubber, etc., these can bedipped, cast, sprayed or otherwise coated on a mandril that is in theshape of a funnel, or alternatively, they can be an extrusion that isthen placed on a mandril that is the shape of a funnel and then byapplying heat, the polymer will take the shape of the mandril. Evenfurther, the extrusion can be placed inside a mold that is the shape ofthe funnel and with the addition of heat and then applying air pressureto the inside of the extrusion, the polymer will expand to the shape ofthe internal configuration of the mold cavity. After heat is removedfrom either of the above-mentioned processes and the system is allowedto cool, the result is a balloon that is in the shape of a funnel.

Alternatively the polymer could be made of an inelastic materialincluding, but not limited to polyethylene, PET, HDPE, etc. These shapescan be accomplished in a similar manner stated above. Further becausethey are inelastic in nature they can be plastically deformed to createthe shape of the funnel.

A balloon funnel catheter 290 is shown in FIGS. 52-54. Catheter 290includes a shaft 292 having a distal end 294 to which an annular balloon296 is secured. Balloon 296 extends past distal end 294. Balloon 296defines a central open region 298 aligned with a main lumen 300 of shaft292. Shaft 292 also includes inflation lumen 302 opening into theinterior 304 of balloon 296. Balloon 296 moves between the uninflated,radially contracted state of FIG. 52 and the inflated, radially expandedstate of FIGS. 53 and 54. Open region 298 is funnel shaped when balloon296 is in the inflated, radially expanded state.

Expanding the Elastomer with the Braid and Applying Heat

The interaction of a braid and a membrane is obviously critical and canbe optimized to provide various funnel shapes and properties.Additionally, the elastomer may be free from attachment to the expandingbraid over one or more sections but still bonded proximally and distallyto the outer member, and inner member, respectively. This constructionhas the benefit of eliminating any protrusions created by bonds or braidgeometries. More specifically, it is preferred to use this technique onthe distal end of the expanding braid section, creating a smooth,uninterrupted funnel shape. This smooth shape may improve fluiddynamics, perhaps by eliminating eddy currents, and allow for morecomplete aspiration of emboli.

It is desirable to create a membrane that is firmly attached to thebraid over a section, yet is free from attachment in another section. Inthis manner the braid can be held in the desired shape (may be finaldeployed shape or any other intermediate position), and the membrane isplaced over the braid. This assembly can then be placed into a heatedmold, or other apparatus to heat the membrane, allowing it to flow andmeld with the braid wires. Insulation may be placed in the mold toprevent the heating of certain sections of the membrane, thus keepingthe membrane free from the braid.

Another aspect of the invention relates to a configuration where thepolymer is shaped with the use of heat in conjunction with the expandingbraid. For example, a thermoplastic elastomer (including, but notlimited to polyurethane, C-Flex, Chronoprene, etc.) could be applied tothe tubular mesh braid (this application could be sprayed, cast dipped,or an extrusion that lies over the braid) and then the tubular meshbraid is actuated so that it expands in any desired shape (including butnot limited to funnel, disc-shape, ovaloid, spherical, conical or anyother desired shape). In this case, the addition of heat would beadvantageous because it would allow the polymer to form into the desiredshape. This could be accomplished during and/or after the tubular meshbraid is expanded. Further, since the interaction of the braid and themembrane is obviously critical it may be necessary to control thisinteraction by bonding the braid to the membrane along its entire lengthor in discrete sections. The elastomer may be free from attachment tothe expanding braid over one or more sections but still bondedproximally and distally to the outer member, and inner member,respectively. This construction has the benefit of eliminating anyprotrusions created by bonds or braid geometries. More specifically, apreferred embodiment is to use this technique on the distal end of theexpanding braid section, creating a smooth, uninterrupted funnel shape.This smooth shape may improve fluid dynamics, perhaps by eliminatingeddy currents, and allow for more complete aspiration of emboli.

In some situations it may be desirable to create a membrane that isfirmly attached to the braid over a section, yet is free from attachmentin another section. The braid can be held in the desired shape (may befinal deployed shape or any other undeployed or intermediate position),and the membrane is placed over the braid. This assembly can then beplaced into a heated mold, or other apparatus to heat the membrane,allowing it to flow and meld with the braid wires. Insulation (PTFEtubing, for example) may be placed in the mold to prevent the heating ofcertain sections of the membrane, thus keeping the membrane free fromthe braid. This forming method is viable for use with any thermoplasticbraid (elastic or inelastic).

Additionally in the case of inelastic polymers, the tubular mesh braidcould be used to actually plastically deform the inelastic polymer. Inthis case it may be advantageous to use tubular mesh braid that has agreater outward radial force so that the plastic deformation may beaccomplished. This increased radial force of the tubular mesh braidcould be accomplished by using yarns in the braid that are larger andstronger or both. In both instances of using the tubular mesh braid as a‘tool’ for creating the shape of the elastomers, air pressure and heatmay be used to aid with the process. In the case of the aforementionedembodiment, where one is creating a balloon in the shape of a funnel,disc, ovaloid, cone, etc, this braid could be used as a tool as well.

A method for securing an end 306 of a tubular braid 308 to a softenableend portion 310 of a tube 312 is illustrated in FIGS. 55-58. End portion310 is inserted into a heated tool 314 and end 306 of tubular braid 308is placed within the open end portion 310 as shown in FIG. 56. Heatedtool 314 causes end portion 310 to soften sufficiently so that when amandril 316 is inserted through tubular braid 308 and into the interiorof heated tool 314 as shown in FIGS. 57 and 58, first end 306 of tubularbraid 308 is driven into softenable end portion 310 to create atube/braid material matrix 316. The resulting bond creates a strong,intimate bond with at most an insubstantial change in either the outsideor inside diameter of tube 312.

Heated tool 314 can be heated in a variety of conventional orunconventional manners, including electrical resistance heating and RFheating. While sensors and feedback loops may be used to keep heatedtool 314 at a desired temperature, heated tool 314 may be made of amaterial having a Curie temperature at the desired operationaltemperature to maintain the tool at the desired operational temperature.

The shape of a radially expandable and contractible tubular device canbe controlled in a manner indicated in FIGS. 59 and 60. FIG. 59illustrates a funnel shaped radially expandable and contractible tubularbraid device 320. Device 320 has different cross-sectional dimensions atdifferent positions, such as positions 322, 323, 324 along its length,when in a radially expanded condition. Device 320 may be radiallyexpandable or contractible naturally or with the aid of an externalforce or stimulus, such as heating or mechanical manipulation. Byvarying the thickness of impregnating material 326, the resistance toradially expansion can be adjusted to achieve the desired shape. Forexample, device 320 has been made with material 326 thickest at position322 with a gradual decrease in thickness at positions 323 and 324, andwith no material past position 324. FIG. 60 illustrates a tubular braiddevice 330 having elastomeric material 332 along a proximal portion 334and along a distal portion 335 of the device to create the expandeddiameter bowling pin shape for device 330. While the application ofmaterial 326, 332 may result in a material having a varying thicknessover at least part of its length, the application may result in amaterial having a constant thickness or a finite number of thicknesses.For example, a number of bands of material, having the same or differentthicknesses and having the same or different axial spacings, may beapplied to the braided material. Also, different materials having thesame or different stretch resistant characteristics may be used. Thematerial may be a generally elastic material or a generally inelasticmaterial or a combination thereof. While it is generally preferred touse an impregnating material 326, an appropriate radialexpansion-inhibiting material may be applied on the outer surface of thebraid or, if properly attached, over the inner surface of the braid.

In some cases it may be desired to impart a shape to a thermoplasticmembrane which can then be used in conjunction with a radiallyexpandable element, such as a tubular braid element or a malecotelement, to help the radially expandable element achieve a desiredradially expanded shape. FIGS. 61 and 62 show the use of a radiallyexpandable device 336 having inner and outer tubes 338, 340 and atubular braid element 342 at the distal ends of tubes 338, 340. Device336 is a tool and could be replaced by other tools, such as a malecotdevice, which would serve the same function. A thermoplastic membrane344 is positioned over tubular braid element 342 and element 342 isradially expanded as shown in FIG. 62. A set is imparted tothermoplastic membrane 344, typically by a heating and cooling cycle;the method of imparting the set will be determined in large part by thematerial from which thermoplastic membrane 344 is made. Membrane 344 maybe an elastic material or an inelastic material. Thermoplastic membrane344 may be applied to tubular braid element 342 by, for example, slidinga tubular membrane over element 342 or by coating tubular braid element342 (or such other tool as may be used) with a thermoplastic liquidmaterial. In the latter case may be desired or necessary to use one ormore separation layers between tubular braid element 342 andthermoplastic membrane 344.

Anastomotic Medical Devices

This aspect of the invention relates to a device/implant, which isparticularly useful for bypassing, joining or re-joining pieces oftissue in the body. Further, this aspect of the invention relates to ameans for bypassing or re-joining tubular structures within the body.The system is applicable for performing an anastomosis between avascular graft and the ascending aorta in coronary artery bypasssurgery, particularly in port-access CABG surgery. Alternatively it maybe used to bypass any diseased vessel (vascular or other vessel/lumen inthe body. A first configuration has two parts: an anchor member, formingthe attachment with the target vessel wall and a coupling member formingthe attachment with the bypass graft vessel. Inserting the couplingmember, with the graft vessel attached, into vessel, completes theanastomosis. A second feature of the invention includes an anastomoticfitting, having an expandable flange, which the vessel is attached whichcontacts the exterior surface of the target vessel. A tailored amount ofpressure is applied by an expandable mechanism that then grips thetarget vessel wall and creates a leak-proof seal between the anastomoticmechanism and the target vessel. A third feature of the invention has aflange to which the vessel attaches, by attaching hooks that areincorporated in the expandable anastomotic device to attach to the wallof the target vessel to form the anastomosis. A method for sealing orjoining a graft vessel to a target vessel at an anastomosis site, thetarget vessel having an opening formed therein. The method includespositioning a fastener made from a deformable material radially adjacentto a free end portion of the graft vessel. The material is transformablebetween a smaller and then larger size, upon application of energy tothe material. The method further includes inserting at least the freeend portion of the device in the target vessel through the opening inthe target vessel. The free end portion of the device is radiallyexpanded to expand the device into intimate contact with an inner wallof the target vessel. The methods and devices represented above havebeen at least generally represented in the attached drawings for theinstant inventions.

Another aspect of the invention is particularly adapted to theanastomotic repair of hollow conduits within the body. For example if atubular conduit in the body is partially, generally, relatively orcompletely blocked, diseased, restricted, etc. and the preferredsolution is removal of the diseased conduit and subsequent anastomoticrepair or perhaps anastomotic repair via a bypass where the instantinventions could be used for joining, re-joining or bypass of thesuspect part of the conduit.

In the case where diseased conduits are removed and it is preferred thatthe conduit be re-joined or even replaced with other autogenous orsynthetic conduit (or a combination thereof), the instant embodimentswould allow the physician to insert a radially expanding tubularstructure within (or over) the remaining ends of the conduit in thebody. It is likely that the radially expanding tubular structure wouldbe placed into the vessel in a condition where it is not fully expandedor in a partially radially contracted condition (or at least a somewhatradially contracted condition; although this is not a condition for theinstant inventions). However, in this case, the device would be placedinto both ends of the vessel (with perhaps pulling the vessels towardone another) in a condition at least equal to or less than the insidediameter of the vessel, but more likely in a somewhat slightlycontracted condition. Both ends of the device may have hooks or otherfasteners or even other connection areas where the device may (or maynot) be attached to the visceral conduits. Additionally tissue gluescommonly available today are likely to be used and may in fact beincorporated into the procedures taught herein. This may be aided withmechanical, chemical or other means or no connection at all may berequired. In the case where some connection mechanism is used/required,those mechanisms may include, but are not limited to hooks, sutures,staples, adhesives, mechanical interlocking, friction, compression, etc.

This instant invention may be enhanced by the use of a tubular meshweave or braid that has been weaved of individual yarns. The use of sucha braid is common both in industry as well as medical device/implants.See, for example, U.S. Pat. Nos. 6,179,860; 6,221,006; 6,635,068;6,258,115 and 6,450,989.

One particular advantage of this tubular mesh braid discussed in thepreceding paragraph is its ability to contract and expand in a tubularfashion. The description of the tubular braid element and coatings of itare included below in this disclosure. (The coating discussed in thepreceding sentence as well as below may or may not be required.)Further, instead of or in addition to the ‘coating’, the braid could beaccomplished with multiple (18-144 or even more or less) ‘yarns’ so thatsome of the yarns could be designed such that they could act as thecoating, so that it is not a coating at all, but is part of the actualbraided mesh itself.

This contraction/expansion phenomenon of the tubular braid element maybe useful in the instant embodiment. For example, a particular length ofthe braid could be formed of a particular diameter. The braid could bestretched or elongated by putting it into a somewhat tensile condition.This would allow the braid diameter to contract and hence fit easilywithin the tubular conduit(s) of the body. Then the braid could beallowed to relax and the diameter would expand radially to apre-determined diameter or to the inside diameter of the visceralconduit. Conversely, the braid could be fabricated a particular diametersmaller than the visceral conduit and then put into compression toexpand it radially to the appropriate diameter to join or re-join thevisceral conduit. This compression or tension could then be permanentlycontrolled if so desired by keeping the braid in an expanded conditionfor an appropriate period of time. Certainly this could be controlledwith the use of ‘memory’ of the braid as is described below in thediscussion of the tubular braid element and elsewhere. Alternatively thebraid could be kept in an elongated/smaller diameter or ashortened/larger diameter by mechanical attachment that keeps the braidin the preferred condition.

This tubular mesh braid could be composed of many different materialsused now in the medical device industry as well as newer yet to bereleased or discovered materials including, but certainly not limited topolymers such as PET's, Silicones, Nylons, Polyesters, Mylar, etc.metals and metal alloys such as Stainless Steels, Elgiloys, NiTIi's(Nickel Titanium alloys, both TWSM (Two Way Shaped Memory) and SuperElastic NiTi's), etc.

Additionally, these radially expanded devices and methods could beaccomplished with a ‘slit tubular’ structure commonly referred to as aMalecot structure that can be easily expanded and contracted by puttingthe tube in compression or extension respectively.

Even further, these radially dilating mechanisms can be accomplished bycurling material like a ‘cinnamon roll’ such that in itssmaller/contracted condition, the walls of the material would becontracted and touch one another (as with a cinnamon roll) and in itslarger diameter state the walls may not be in contact with one another.This cinnamon roll can be accomplished by ‘rolling’ the sheet (withporosity, holes, coverings, films, membranes, drugs, compounds, etc.) ofmaterial into a tube/cylindrical like condition in a small diameter andthen when in the desired location, the rolled sheet is allowed to oreffected to at least partially ‘unroll’ into at least a partiallytubular structure desired.

Even further yet, the instant inventions and methods can be accomplishedby a system of a sheet of material that is longer than it is wide (e.g.like a ribbon). The longer dimension is then programmed to a tubularconfiguration by ‘wrapping’ it around a small cylindrical mandril (orother means) and treating it to keep in that small tubularconfiguration. Then when in the desired location, the smaller tube canbe activated to become a larger tubular configuration. One such way toaccomplish this is with TWSM NiTi mentioned above and disclosed as aMulti-Porous Stent in U.S. Pat. No. 6,258,115.

In all instances these mechanisms may be covered with a film of elasticor inelastic material. Further this film may be incorporated into themechanisms as opposed to covering them. Such films, coverings or otherincorporated materials may be, but are not limited to the following:silicone, nylons, polyethylenes, wovens, hybrids, PET's, woven metals,PTFE'S, Expandable PTFE's, FEP's, Teflon's, and a variety ofbioabsorbable materials such as hydromers, collagens, polymers, vicryls,autogenous substances (animal, human or plant).

There may be a support wire(s) that may extend through or alongside theexpandable channel devices at its distal and proximal ends (or nearthem). These wires may be used to help deploy or undeploy the radiallyexpanding elements. Further, these wire(s) may be used to help keep thepreferred condition when in the preferred position in the host. Thesupport wire(s) may be one, two, three, four or more in number and maybe located inside or outside the tubular structure. They may be used toput the mechanism into a tensile or compressive condition that willallow it to become a small diameter or larger diameter condition. Thesewires can be made permanently attachable to keep the desiredconfiguration by attaching them permanently to keep the mechanism in thedesired shape. The distal end of the core is attached to the distal endof the annular braided element (or other mechanism described herein) andthe distal end of the shell is attached to the proximal end of theannular braided element. Thus movement of the core and shell relative toone another moves the braided element from a radially retractedposition, which is useful for insertion into the body in a smallcondition to a radially expanded position, which expands it to thesidewall of the channel in the body.

A device made according to this aspect of the invention is used forintervention into the tubular channels (arteries, veins, biliary tract,urological tract, gastro-intestinal tract, stents, grafts, sinuses,nasopharynx, heart, ears, etc.) or hollow cavities (stomach, gallbladder, urinary bladder, peritoneum, etc.) of the body. Additionallythe instant invention may be used in solid or semi-solid tissueincluding, but not limited to breast, liver, brain, pancreas, lungs etc.It is particularly convenient to use in an operating room, surgicalsuite, interventional suite, Emergency Room, patient's bedside, etc.environment. One preferred embodiment of this device is that theflexible shaft is inserted into the tissue, tubular channel or hollowcavity of the body usually through percutaneous access or via a surgicalincision. In the case of lumens that enter and exit the body naturally,the device may enter through one of those entry or exit paths (i.e.rectal opening, mouth, ear, etc.).

Additionally, other techniques may be used for removal assistance suchas the use of lytic agents, laser energy, dissolving agents, hydraulicassistance, mechanical agitation, vibration, ultrasonic energy or anyother variety of assistance that will aid in the removal. Imageintensification (Ultrasound, fluoroscopy, MRI, etc.) may be used as wellto help with assuring the technique/removal is successful. Additionally,direct visualization using cameras or endoscopes may be used as well.

Further, materials disclosed could be of some hybrid elastic/inelasticmaterial or compliant material. Even further, the balloon may be aidedwith some other mechanical substructure that aids in the outward radialforce that is created by the balloon. Further when balloons are used,filaments such as thin strips of polymers such as Mylar, pet,polyethylene, etc., could be used to create a desired effect wheninflating the balloon (such as shape). All of these configurations mayor may not have a roughened texture on the exterior surface that willaid in the removal of the obstruction or adherence to tissue.Alternatively, all of the above mentioned configurations could have aseparate or additional material applied over the expandable mechanismthat is a membrane, which may or may not be roughened. The roughenedsurface on the expandable mechanism is easily accomplished in themanufacturing environment. One such way is to create bubbles in a liquidslurry of the polymer prior to its solid curing. Another might be theaddition of dissolvable crystals to the surface of the liquid polymerprior to its cure. These dissolvable crystals could then be removed(washed off) after curing of the polymer.

Another configuration that could be used for the expandable mechanism isa mechanism(s) known as a malecot. This malecot is a commonconfiguration used in catheters for holding them in place (in the caseof feeding tubes in the intestines or stomach). It is usually apolymeric tube that has more than one, but usually two or more slitssymmetrically opposed. When the distal tip of the malecot is put intocompression (usually by pulling an inner wire or mandril or tube), thesides of the polymer are pushed outward to create a larger diameter onthe distal tip. This larger diameter is larger than the body/shaft ofthe device. In the case of a malecot type configuration (as with theinflatable mechanism(s) mentioned above), the surface of the malecotcould be roughened or a separate membrane (attached or not) could be putover or under the malecot so that it is roughened or strengthened.Further, a membrane that connects the ribs or wings of a malecot iseasily fabricated to increase the surface area of the malecot ribs orwings alone.

Yet, another alternative design of the expandable mechanism is one thathas similarities to the malecot, but uses a multi-stranded braid on thedistal end. When the braid is put into compression, the braid is pulledtogether and it flares out to create a larger diameter on the distalend. Changing the pore size along the braid so that the holes in thebraid go from none to large holes/pores easily modifies the braid. Thiscan be accomplished by braiding the braid with metals and polymers andmelting the polymers away or by simply braiding at different rates whilebraiding that causes different pore sizes also known in the braidingindustry as pics per inch. This is easily accomplished ‘on the fly’while braiding by using a programmable braider. The braid pics per inchchange with time as the tubular mesh braid is being braided. Thisvarying pore size may have a number of advantages to the currentinvention. It could aid with stopping porosity when needed and allowingporosity when you need it. For example, it is possible that ingrowthwould be desired in contact with tubular body structures at certaintimes and that there be no porosity when trying to achieve a leak freeenvironment (perhaps in between the two tubular structures beingattached or when bypassing.

Alternatively, either the braid or the malecot can have a permanent setput into in so that it is normally open with the larger diameter. Inthis case, when it is put into tension (usually from some inner (orouter) core wire or mandril), it collapses down to the diameter of theshaft of the device.

Alternatively, too much abrasive action on the surface of themechanism(s) may be deleterious to the patient as well. In the case ofthe braided configuration, some smoothener may be required so that justthe appropriate amount of friction is realized for effective obstructionremoval. Further, the realized rigidity of any of the type ofmechanism(s)s must be optimized for this removal in the particularapplication.

A radially collapsible tubular channel can also be fabricated fromseveral materials and configurations. One preferred configuration is amulti-stranded braided device. The strands can be made of any materialthat would be useful for a particular application (polymers likepolyester, nylon, Mylar, etc.) or, metal (stainless steel, NickelTitanium Allow (Nitinol), platinum, etc.). Certainly, the potentiallyuseful materials are not constrained to those materials listed.Additionally, the mechanism channel may be coated or encased in anelastomeric or other covering. Further, the mechanism channel may befabricated of a material that will enlarge due to different forces thanthat of the braid mentioned previously. One other such force derivedmechanism could be a material that swells/enlarges when put into a moistenvironment. Another such force derived mechanism is one thatswells/enlarges when thermal energy is applied such as Two Way ShapedMemory Alloy (TWSMA) such as a Nickel-Titanium alloy. Yet, another maybe one that occurs from an electrical, magnetic or other mechanicalconfiguration/design/force.

The Tubular Braid Elements

The mechanisms described above include an elongate tube; an elongatemandril inside the tube and an expandable tubular braid. The elongatemandril extends from the proximal end of the device to the distal end.The elongate tube usually extends from close to the proximal end of thedevice to close to the distal end. The distal end of the tubular braidis bonded to the distal end of the inner elongate mandril. The mandrilmay extend beyond the tubular braid. The proximal end of the tubularbraid is bonded to the distal end of the elongate tube.

The braid may be open, but may be laminated or covered with a coating ofelastic, generally inelastic, plastic or plastically deformablematerial, such as silicone rubber, latex, polyethylene, thermoplasticelastomers (such as C-Flex, commercially available from ConsolidatedPolymer Technology), polyurethane and the like. The assembly of tube,mandril and braid is introduced percutaneously in its radiallycompressed state. In this state, the outside diameter of the braid isclose to the outside diameter of the elongate tube. This diameter is inthe range of 10 to 500 mils, and usually 25 to 250 mils (i.e. thousandthof an inch) (0.25 to 12.7 mm, usually 0.64 to 6.4 mm). After insertion,moving the mandril proximally with respect to the tube expands thetubular braid.

The tubular braid is preferably formed as a mesh of individualnon-elastic filaments (called “yarns” in the braiding industry).However, it can have some elastic filaments interwoven to create certaincharacteristics. The non-elastic yarns can be materials such aspolyester, PET, polypropylene, polyamide fiber (Kevlar, Dupont),composite filament wound polymer, extruded polymer tubing (such as NylonII or Ultem, commercially available from General Electric), stainlesssteel, Nickel Titanium (Nitinol), or the like so that axial shorteningcauses radial expansion of the braid. These materials have sufficientstrength so that the tubular braided element will retain its expandedcondition in the lumen of the body while removing the matter therefrom.Further, all expandable mechanisms described heretofore, can bemanufactured using shape memory materials so that they are selfexpanding or even expandable when certain temperatures or thermalenergies are delivered to the mechanisms. Such material characteristicscan be accomplished with different programming methods such as, but notlimited to Two Way Shape Memory (TWSM) alloys.

The braid may be of conventional construction, comprising roundfilaments, flat or ribbon filaments, square filaments, or the like.Non-round filaments may be advantageous to decrease the axial forcerequired for expansion to create a preferred surface area configurationor to decrease the wall thickness of the tubular braid. The filamentwidth or diameter will typically be from about 0.5 to 50 mils (0.013 to1.3 mm), usually being from about 5 to 20 mils (0.13 to 0.51 mm).Suitable braids are commercially available from a variety of commercialsuppliers.

The tubular braids are typically formed by a “Maypole” dance of yarncarriers. The braid consists of two systems of yarns alternately passingover and under each other causing a zigzag pattern on the surface. Onesystem of yarns moves helically clockwise with respect to the fabricaxis while the other moves helically counter-clockwise. The resultingfabric is a tubular braid. Common applications of tubular braids arelacings, electrical cable covers (i.e. insulation and shielding),“Chinese hand-cuffs” and reinforcements for composites. To form abalanced, torque-free fabric (tubular braid), the structure must containthe same number of yarns in each helical direction. The tubular braidmay also be pressed flat to form a double thickness fabric strip. Thebraid weave used in the tubular braid of the present invention willpreferably be of the construction known as “two dimensional, tubular,diamond braid” that has a 1/1 intersection pattern of the yarns which isreferred to as the “intersection repeat”. Alternatively, a Regular braidwith a 2/2-intersection repeat and a Hercules braid with an intersectionrepeat of 3/3 may be used. In all instances, the helix angle (that beingthe angle between the axis of the tubular braid and the yarn) willincrease as the braid is expanded. Even further, Longitudinal Lay-Inscan be added within the braid yarns and parallel to the axis to aid withstability, improve tensile and compressive properties and modulus of thefabric. When these longitudinal “Lay-In” yarns are elastic in nature,the tubular braid is known as an elastic braid. When the longitudinalyarns are stiff, the fabric is called a rigid braid. Biaxially braidedfabrics such as those of the present invention are not dimensionallystable. This is why the braid can be placed into an expanded state froma relaxed state (in the case of putting it into the compressive mode).Alternatively this could be a decreased/reduced (braid diameterdecreases) state when put into tension from the relaxed state. When putinto tension (or compression for that matter) the braid eventuallyreaches a state wherein the diameter will decrease no more. This iscalled the “Jammed State”. On a stress strain curve, this corresponds toincrease modulus. Much of the engineering analyses concerning braids arecalculated using the “Jammed State” of the structure/braid. Thesecalculations help one skilled in the art to design a braid withparticular desired characteristics. Further, material characteristicsare tensile strength, stiffness and Young's modulus. In most instances,varying the material characteristics will vary the force with which theexpanded condition of the tubular can exert radially. Even further, thefriction between the individual yarns has an effect on the forcerequired to compress and un-compress the tubular braid. For the presentinvention, friction should be relatively low for a chosen yarn so thatthe user will have little trouble deploying the engaging element. Thisis particularly important when the engaging element is located asignificant distance from the user. Such is the case when thepercutaneous entry is the groin (Femoral Artery for vascularinterventions) and the point of engaging the engaging element is somedistance away (i.e. the Carotid Artery in the neck). Similarly, this istrue for long distances that are not vascular or percutaneousapplications.

Coating of the Tubular Braid

Throughout this disclosure, it is mentioned that the tubular braid maybe coated with a material so that it may have no porosity or variableporosity within the individual filaments of the braid. This is animportant configuration of the present invention and in certaininstances may be critical (i.e. when a cancer is being removed from asmall puncture hole, cancerous tissue must not be able to leak outthrough the walls of the tubular braid because the cancer may be seededalong the tract. This is important in the case of laparoscopic surgeryas well. In fact, it may be important in many instances, not only wherecancer is apparent.) One simple way to cover the tubular braid is toattach tubing over it. This has been done to prototypes of the presentinvention and works quite well. Elastomeric and inelastic coverings havebeen used. In some instances thermoplastic coverings were used and thenheat and compression was applied along the tubular braid to melt it intothe braid filaments. This works well. The braid was expanded from itsoriginal small diameter by sliding a mandril into the tubular braid.Once the braid is expanded, a liquid thermoset elastomer including, butnot limited to silicone rubber, latex rubber, etc. or thermoplasticmaterial including, but not limited to polyurethane was coated via aspray, dip, brush or other method. When the material cured, the mandrilwas removed and the tubular braid could be pulled on both ends (put intocompression) and the tubular braid would go back to its originaldiameter. This is important for several reasons; the method describedhere allows the material to be applied within the filaments instead ofover the filaments. This decreases the overall diameter of the tubularbraid significantly as opposed to putting a covering over it. Further,the integrity of the material in between the filaments as opposed toover the filaments is increased because as the expandable channel ispushed forward, the material is hidden within the braid and hencedoesn't see the forces of the tissue against it. Using a covering overthe braid, the forces during the pushing are directly transmitted to thecovering over the braid. Even further, the reliability and cost tomanufacture are greatly improved. Even further and of extreme import isthe fact that using a liquid that cures or a thermoplastic covering thatis melted into the braid as opposed to covering it allows for varyingthe porosity along the tubular braid. This is extremely important inthose cases where variable porosity is desired.

Device Testing

Prototypes of the mechanisms were fabricated from the materialsdisclosed heretofore and of the dimensions commensurate with thisdisclosure.

Further, several different types of tubular braid were coated and/orcovered with polymer elastomers and inelastomers as describedheretofore. In one case, the braid was expanded to some diameter greaterthan the relaxed and smaller diameter. This was accomplished using aTeflon mandril. With the tubular braid in this somewhat expandedcondition, the assembly was coated with liquid silicone rubber. When itdried, putting the system into tension so that the smaller originaldiameter was achieved again could elongate the assembly. It could thenbe put into compression and thusly shortened so that it would expand andthe braid was covered so that there could be no holes in between thefilaments of the braid. Further, the overall diameter of the tubularbraid as not increased except for maybe 0.0001″ (0.0025 mm). Evenfurther, trap devices were made whereby the silicone rubber was sprayedor painted onto the tubular braid when it was in the deployed/expandedcondition. Once dried, the assembly could be un-deployed and thenre-deployed with ease and without any holes between the filaments.Lastly, tubular braids were coated as described above with only partialcoating to create variable porosity along the braid. Even further, thetotally coated tubular braid was easy to puncture so that variableporosity was achieved as well. Further, multi-stranded braided tubingwas braided using over 100 individual yarns made of thermoplasticmaterials and metallic materials. After braiding was completed,individual yarns were removed to change porosity. Alternatively when acombination of metal and thermoplastic yarns were used, thethermoplastic yarns were heated and melted away from the tubular mesh tochange the pore size by leaving the metal or polymers with higher melttemperatures (or in the case of thermoset polymers, higher temperatureresistant materials) leaving the metal or higher temperature resistantmaterials in place.

An exemplary device has the following characteristics:

Working Length

10-500 cm

Working Diameter

The expandable mechanism has an outer diameter that ranges from 0.006″to 0.450″ (0.15 mm to 1.14 cm), but can extend to smaller and largersizes as technology and procedures require. The expandable mechanisms ofthe instant invention would be small in its un-deployed state in therange of 0.020-0.090 inches (0.51 mm to 2.3 mm) but would be expandableto diameters of with a tenfold increase or even larger.

Physical Configuration

The device of the instant invention may have conventional lubriciouscoatings to enhance introduction into the target body lumen, e.g.hyaluronic or other equivalent coatings. Further, the technician mayapply a lubricious coating just before surgery. Also, a variety of drugsmay be used with the device, as well as the above-described devices, fora variety of reasons such as reducing infection and/or rejection, and inthe case of vascular situations, drug eluting mechanism can be added tohelp prevent stenosis or restenosis. Such drugs or compounds may be butare not limited to Sirolimus—a immunosuppressant drug usually used toprevent rejection in organ transplants—elutes from the stent into thevessel wall over the period when the scar tissue may be growing.Paclitaxel, a chemotherapy drug, may also be used. The Paclitaxel maygradually release directly into the coronary artery wall to prevent therestenosis process; this may be accomplished by embedding the materialin the polymer as opposed to coating the device. The same may be truefor Sirolimus.

As an advantage of the instant invention, the device will be lessdifficult to feed it to the desired location in the body due to itsdecreased size. Another advantage of the instant invention would be theease with which bypassing or anastomosis can be accomplished. It can bedone in a percutaneous fashion as opposed to an open, surgical procedureas well. Over the past decades, it has been proven that percutaneousintervention as compared to open surgical intervention has shown a greatdecrease in morbidity and mortality as well. This decreased difficultywill decrease cost due to time in the Operating Room (Operating Roomscosts are estimated in excess of $90 dollars per minute in the U.S.)

FIG. 63 illustrates the distal end of an anastomotic medical device 348including a tube 350 having a tubular braid anchor member 352 secured toa first end 354 thereof. Device 348 also includes an actuator 355extending through tube 350 past the second end 356 of tube 350, seeFIGS. 64 and 65, and connected to the distal end 358 of anchor member352. A dilator 360 passes through tube 350 and helps to guide medicaldevice 348 through a relatively small opening 362 in tubular structure364 of a patient. FIG. 63 illustrates device 348 passing into a bloodvessel near the diseased obstruction 366. Finally, device 348 includes aguide wire 368 passing centrally through dilator 360. After beingproperly positioned, dilator 360 and guide wire 368 are removed andactuator 355 is pulled, as indicated in FIG. 65, to cause anchor member352 to expand as shown in FIG. 66. If desired, anchor member 352 couldbe self expanding or expandable on the application of, for example,heat. FIG. 67 illustrates anchor member 352 including hooks 370 deployedto help secure anchor member 352 in place. Hooks 370 can be deployed byfirst pushing them distally and pulling them proximally to lock/hooktubular structure 364 or by axially contracting anchor member 352 toexpose the hooks. Note that while tubular structure 364 is shown to beradially expanded when anchor member 352 is secured in place, suchdistention of the tubular structure may not be required.

An example of tubular mesh braid 372 is shown in FIGS. 68 and 69. Braid372 can easily changed diameter by 1000% due to compression/tensionforces as illustrated by arrows 374, 376 or due to a permanent set putinto braid 372 during manufacturing. Alternatively, temperature change,or electrical, mechanical or magnetic forces, could be used to createthe change in diameter as desired. FIG. 70 illustrates tubular meshbraid 372 including hooks 378. Hooks 378 can be deployed due toforeshortening of braid 372. This foreshortening may occur with otherexpandable mechanisms disclosed above so that hook deployment can beaccomplished using such other expandable mechanisms.

Anastomotic medical device 348 may have second end 356 positionedexternally of a patient's body and provide access to a single tubularstructure. However, two anastomotic medical device 340 may be used in apatient and connected to two different tubular structures within apatient or may be used to bypass a portion of the same tubularstructure. In either case, the second ends 256 of the two anastomoticmedical devices 348 are secured to one another in an appropriatefashion. The following FIGS. 71-74 show various structures for joiningthe ends of a tubular structure of a patient; the structure may also beused to join second ends 356 in appropriate cases.

FIG. 71 illustrates a tubular braided type of anastomotic medical device380 covering the opposed ends 382, 384 of a severed tubular structure364. Ends 382, 384 are shown to be abutting but may be separated aswell. The relaxed state of medical device 380 is a smaller diameterstate so that device 380 squeezes tubular structure 364 to maintain ends382, 384 in place. If desired, the central portion of device 380 couldbe made to be liquid impervious or the entire device may be liquidimpervious. FIG. 72 illustrates the use of a radially outwardlyexpanding anastomotic medical device 386 within the interior of tubularstructure 364 to join ends 382, 384. Ends 382, 384 may be spaced apartfrom one another or abutting, as indicated in dashed lines in FIG. 72.An appropriate portion of device 386 is typically liquid impervious toprevent leakage. If desired, a radially inwardly expanding device 380could be used on the outside of tubular structure 364 and a radiallyoutwardly expanding device 386 could be used on the inside of tubularstructure 364 at the same junction. FIGS. 73 and 74 illustrateanastomotic medical devices 380, 386 but with the addition of hooks 378to help secure the anastomotic medical devices in place. Variousmembranes, films, wovens, and coatings could be used to aid with thefunction of the mechanisms disclosed above. Multiple porosities may alsobe advantageous for different applications. Drugs and other therapeuticagents may also be used in association with the above anastomoticdevices.

FIG. 75 illustrates a variable porosity anastomotic device 388 in theform of a straight tube. FIG. 76 illustrates a variable porosityanastomotic device 390 in the form of a tapered tube. If such structureswere placed inside the body channel, it may be desired to have thesmaller pores at the central portion and the larger pores at the outerends. The materials used for the various anastomotic medical devicesdescribed above could be all non-absorbable/degradable, allabsorbable/degradable or a combination of the two depending upon theparticular anastomotic application.

FIGS. 77 and 78 illustrate a malecot-type anastomotic device 392 andradially contracted and radially expanded states. Device 392 is shownhaving four slits 393, although two or more may suffice for radialexpansion. FIGS. 79 and 80 illustrate the application of tension force,indicated by arrows 376, and compression force, indicated by arrows 374,to device 392 to place the device in radially contracted and radiallyexpanded states

FIGS. 81 and 80 illustrate a variable porosity expandable device 394having a variable porosity braid 396 placeable in the radiallycontracted and radially expanded states of FIGS. 81 and 82 by slidinginner tube 398 within outer tube 400 as indicated by the arrows in theFigs.

FIGS. 83 and 84 illustrate a variable diameter device 402 in a radiallycontracted state in FIG. 83 and a radially expanded state in FIG. 84.Device 402 includes a spiral ribbon 404 of material constructed so thatthe lateral edges 406 of spiral ribbon 404 are generally adjacent, thatis close to one another or overlapping, to provide a generallycontinuous cylindrical surface so to approximate a solid cylinder. FIG.85 is an end view of a coiled cylinder 408.

FIGS. 86-87 illustrate a self expanding, expandable channel anastomoticdevice 410 having two slits 412 formed in outer tube 414. The expandableend 416 of device 410 can be kept in its radially contracted state ofFIG. 86 by pushing on inner tube 417, or allowed to assume its radiallyexpanded state of FIG. 87 by permitting inner tube 417 to move in thedirection of the arrow. FIG. 88 illustrates an anastomotic device 418that naturally assumes the radially expanded state of FIG. 88 but isinitially maintained in a radially contracted state by an outer tube,not shown. When expansion is desired, the outer tube is withdrawn orotherwise removed allowing expansion of expandable end 416 to occur. Theanastomotic device 420 of FIGS. 89-91 is similar to the device of FIGS.86 and 87 but naturally assumes the radially contracted state of FIG.89. To place the device in a radially expanded state, inner tube 417 ispulled as indicated in FIG. 90. Although not illustrated, variousmembranes, films, etc. can be used to fill in all or part of the spacescreated by slits 412 in the expandable ends 416 of the devices.

An anastomotic device 422 is shown FIGS. 92 and 93 to include an outertube 424 and an inner, self expanding braided member 426. Braided member426 is initially constrained by outer tube 424 that may be flexibleand/or lubricated. Braided member 426 may be permitted to expand bysliding outer tube 424 in a retrograde fashion in the direction of arrow428 or by pushing braided member 426 in the direction of arrow 430, orboth. Other types of structures, including a malecot such as shown FIGS.86 and 87, a coiled tubular device such as shown in FIGS. 83 and 84, ora coiled cylinder device such as shown in FIG. 85, could be mechanizedin such a fashion.

FIG. 94 illustrates an alternative to the tubular braid anchor member352 of FIGS. 63 and 66. Anastomotic device 434 includes a tube 436having an inner expandable mechanism 438 or both an inner expandablemechanism 438 and an outer expandable mechanism 440 used to engage theperiphery of opening 362 in tubular structure 364. Expandable mechanisms438, 440 may be tubular mesh braid as shown or some other type ofexpandable device, such as an inflatable balloon, a malecot, a coiledtubular device or coiled cylindrical device.

FIG. 95 illustrates a tubular mesh braid 444 mounted to the exterior of,for example, an endoscope or other elongate device within a tubularstructure 364, for example the bowl or intestine. FIG. 96 illustratesbraid 444 in an expanded state as result of pushing on the braid asindicated by the arrows. Advancing the endo device causes tubular braid444 to contract down back on the endo device as shown in FIG. 97.

Other modification and variation can be made to the disclosedembodiments without departing from the subject of the invention asdefined in following claims.

Any and all patents, patent applications and printed publicationsreferred to above are incorporated by reference.

What is claimed is:
 1. A catheter device for use in performingprocedures in blood vessels, such as removing clots, the devicecomprising: an outer tube having a proximal end and a distal end; aninner tube moveably disposed within the outer tube and having a proximalend, a distal end and an inner tube lumen therebetween; a flexible,tubular, braided mesh sleeve formed on a conically-shaped mandril andcomprising multiple Nitinol strands, each of the strands having adiameter of 0.0015-0.0025 inches, wherein the sleeve comprises: a distalend joined to the distal end of the outer tube; a proximal end joined tothe distal end of the inner tube; a polymer-coated portion; and anuncoated portion; wherein the sleeve moves from a radially contractedconfiguration to a radially expanded configuration by moving at leastone of the tubes to position the outer tube farther proximally relativeto the inner tube, and wherein, when the tubular sleeve is in theradially expanded state, an inner portion of the tubular sleeve has afunnel-shaped surface and an opening in fluid communication with theinner tube lumen.
 2. A device as in claim 1, wherein the polymer-coatedportion of the sleeve is fluid-impermeable, and wherein the uncoatedportion is permeable.
 3. A device as in claim 1, wherein thepolymer-coated portion of the sleeve comprises a flexible, elastic filmon an outer surface of the sleeve.
 4. A device as in claim 1, whereinthe sleeve is inverted before being attached to the outer and innertubes.
 5. A device as in claim 1, wherein the sleeve further comprises aU-shaped, direction-reversing region between the inner portion of thesleeve and an outer portion of the sleeve, and wherein a location of theU-shaped portion on the sleeve changes as relative positions of theinner and outer tubes change.
 6. A device as in claim 1, wherein thesleeve is adjustable to occlude differently sized blood vessels byadjusting relative positions of the inner and outer tubes.
 7. A deviceas in claim 1, wherein a distal portion of the sleeve is heat treated.8. A device as in claim 1, wherein a proximal portion of the sleeve iscoated with an elastic polymer to resist expansion and buckling, andwherein a distal portion of the sleeve is uncoated to promote bucklingof the distal portion.
 9. A device as in claim 1, wherein a proximalportion of the sleeve has a greater pic count than a pic count of adistal portion of the sleeve.
 10. A catheter device for use inperforming procedures in blood vessels, such as removing clots, thedevice comprising: an outer tube having a proximal end and a distal end;an inner tube moveably disposed within the outer tube and having aproximal end, a distal end and an inner tube lumen extendingtherebetween; a flexible, tubular, braided mesh sleeve formed on aconically-shaped mandril and comprising multiple strands, each of thestrands having a diameter of 0.0015-0.0025 inches, wherein the sleevecomprises: a distal end joined to the distal end of the outer tube; aproximal end joined to the distal end of the inner tube; a distalportion coated with a first polymer coating; and a proximal portioncoated with a second polymer coating, wherein the first coating is morestretchable and less stiff than the second coating; wherein the sleevemoves from a radially contracted configuration to a radially expandedconfiguration by moving at least one of the tubes to position the outertube farther proximally relative to the inner tube, and wherein, whenthe tubular sleeve is in the radially expanded state, an inner portionof the tubular sleeve has a funnel-shaped surface and an opening influid communication with the inner tube lumen.
 11. A device as in claim10, wherein the strands of the sleeve comprise a material selected fromthe group consisting of Nitinol, stainless steel, titanium, a polymerand tungsten.
 12. A device as in claim 10, wherein sleeve is invertedbefore being attached to the outer and inner tubes.
 13. A device as inclaim 10, wherein the sleeve further comprises a U-shaped, directionreversing region between the inner portion of the sleeve and an outerportion of the sleeve, and wherein a location of the U-shaped portion onthe sleeve changes as relative positions of the inner and outer tubeschange.
 14. A device as in claim 10, wherein the sleeve is adjustable toocclude differently sized blood vessels by adjusting relative positionsof the inner and outer tubes.
 15. A device as in claim 10, wherein adistal portion of the sleeve is heat treated.
 16. A method for removinga clot from a blood vessel, the method comprising: advancing a clotremoval catheter through the blood vessel in a direction of blood flowto position a distal end of the catheter near the clot; retracting anouter tube of the catheter relative to an inner tube of the catheter, tocause a flexible sleeve to expand out of the distal end of the catheterto contact an inner wall of the blood vessel, wherein upon expansion,the flexible sleeve forms a funnel-shaped inner surface in fluidcommunication with a lumen of the inner tube of the catheter; allowingblood to flow through an uncoated portion of the flexible sleeve, whilepreventing blood from flowing through a coated portion of the sleeve;and directing the clot into the lumen of the inner tube through thefunnel-shaped inner surface of the flexible sleeve.
 17. A method as inclaim 16, wherein retracting the outer tube causes the sleeve to form aseal with the inner wall of the blood vessel.
 18. A method as in claim16, further comprising adjusting a position of the outer tube relativeto a position of the inner tube to provide the expanded flexible sleevewith a desired diameter to fit the inner wall of the blood vessel.
 19. Amethod as in claim 16, further comprising moving at least one of theinner tube relative to the outer tube or the outer tube relative to theinner tube, to adjust a size of the expanded flexible sleeve.
 20. Amethod as in claim 16, wherein directing the clot into the lumencomprises applying suction force through the lumen.